Drug Approvals: April 2025 - Prime Therapeutics
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Drug Approvals: April 2025
Monthly update on newly approved specialty and traditional drugs, new indications and first-time generic launches
April 29, 2025
Specialty
March 26, 2025 – diazoxide choline (Vykat XR)
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New Drug Application (NDA) approval; Orphan Drug, Priority Review
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Benzothiadiazine derivative
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Indicated for the treatment of hyperphagia in adults and pediatric patients ≥ 4 years of age with Prader-Willi syndrome (PWS)
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Extended-release (ER) tablets: 25 mg, 75 mg and 150 mg; cannot be substituted with diazoxide oral suspension
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Recommended starting dosage and titration schedule are based on the patient's body weight; taken orally once daily
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Approval was based on a 16-week, double-blind, placebo-controlled withdrawal study period (Study 2-RWP; n=77); following an open-label study period, patients were randomized to continue their current oral dosage of Vykat XR or be switched to placebo; patients who switched to placebo demonstrated a statistically significant worsening of hyperphagia compared with patients who remained on Vykat XR as assessed by change from baseline in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Total Score (range, 0 to 36; higher scores indicate greater overall severity of hyperphagic and food-related behaviors) at the end of the 16-week randomized withdrawal study period (least-squares mean difference, -5; 95% confidence interval [CI], -8.1 to -1.8).
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Vykat XR is the first and only United States (U.S.) Food and Drug Administration (FDA)-approved treatment for hyperphagia in patients with PWS, a rare, genetic neurodevelopmental disorder; the hallmark symptom of PWS is chronic hyperphagia that can be life-threatening due to intense persistent sensation of hunger, food preoccupations and food-related behavior problems leading to mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and comorbidities (e.g., diabetes, obesity, cardiovascular disease); the mechanism of action for Vykat XR in PWS is unknown; somatropin (Genotropin, Norditropin, Omnitrope) is indicated for pediatric patients with growth failure due to PWS but does not address the underlying hyperphagia
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Product is available from Soleno with an average wholesale price (AWP) of $1,065.60 per 150 mg tablet, $532.80 per 75 mg tablet and $177.60 per 25 mg tablet
March 28, 2025 – fitusiran (Qfitlia)
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NDA approval; Breakthrough Therapy, Fast Track, Orphan Drug
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Antithrombin-directed small interfering RNA (siRNA)
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Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ≥ 12 years of age with hemophilia A or B with or without factor VIII or IX inhibitors
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Solution for injection: 50 mg/0.5 mL single-dose prefilled pen and 20 mg/0.2 mL single-dose vial
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Recommended starting dosage is given once every two months administered subcutaneously (SC) by patients and/or caregivers (for pediatric patients 12 to 17 years of age, should be administered by or under the supervision of an adult); antithrombin (AT) levels should be monitored using an FDA-cleared test (e.g., Innovance AT companion diagnostic) before starting, at weeks 4, 12, 20 and 24 and after any dose modifications; the dose and/or dosing interval, if needed, should be adjusted to maintain AT activity between 15% and 35%; following identification of the patient’s target dose, AT activity is measured annually or if bleeding control is inadequate; the prescribing information details bleeding management
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Fitusiran was evaluated in two randomized, multicenter, open-label Phase 3 trials (ATLAS-INH [with inhibitors] and ATLAS-A/B [without inhibitors]) in which patients received either a fixed fitusiran monthly dose (unapproved dose, led to excessive clotting) or their usual on-demand treatment consisting of bypassing agents (BPAs) on-demand (patients with inhibitors) or clotting factor concentrates (CFCs) on-demand (patients without inhibitors) for nine months followed by a long-term, open-label extension study (ATLAS-OLE) with an adjustable dose of fitusiran (based on AT activity); efficacy was evaluated by comparing the fitusiran AT-based dosing regimen during ATLAS-OLE (n=213) to the on-demand control data from ATLAS-INH and ATLAS-A/B; in patients with inhibitors receiving the AT-based dosing regimen of fitusiran, there was a 73% mean reduction in estimated annualized bleeding rate (ABR) compared to patients who received on-demand treatment with BPAs (p=0.0006); similarly, in patients without inhibitors, those receiving the AT-based dosing regimen had a 71% mean reduction in estimated ABR compared to those who received on-demand treatment with CFCs (p<0.0001)
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Qfitlia is a first-in-class siRNA targeting AT; for hemophilia A, other similar agents include the factor VIII concentrate Altuviiio, also indicated for routine prophylaxis to decrease the frequency of bleeding episodes in adults and children (once weekly intravenous [IV] dosing), and the bispecific factor IXa- and factor X-directed antibody emicizumab-kxwh (Hemlibra), indicated to prevent or reduce the frequency of bleeding episodes in adults and children with or without inhibitors (maintenance dosing SC weekly, every two weeks or every four weeks); for hemophilia A and B, marstacimab-hncq (Hympavzi) and concizumab-mtci (Alhemo) are tissue factor pathway inhibitor (TFPI) antagonists indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ≥ 12 years of age without inhibitors (Hympavzi; weekly SC maintenance dosing) and with inhibitors (Alhemo; daily SC dosing)
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Boxed warning for thrombotic events and acute and recurrent gallbladder disease
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Product is available from Genzyme with an AWP of $193,680 per 50 mg/0.5 mL auto-injector and $77,472 per 20 mg/0.2 mL solution in a vial
April 2, 2025 – atrasentan (Vanrafia)
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NDA approval; Accelerated Approval, Orphan Drug, Priority Review
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Endothelin receptor antagonist
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Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g
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As this indication was approved under Accelerated Approval based on a reduction of proteinuria, it has not been determined if Vanrafia slows kidney function decline in IgAN; continued approval for this use may require demonstration of benefit in confirmatory clinical trials
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Tablets: 0.75 mg
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Recommended dosage is one tablet orally once daily with or without food
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Approval was based on results from a prespecified interim analysis of a randomized, double-blind, placebo-controlled Phase 3 study (ALIGN; n=270) that demonstrated a statistically significant reduction in proteinuria at 36 weeks with atrasentan compared to placebo as measured by the geometric mean percentage change in UPCR relative to baseline which was -38.1% with atrasentan compared with -3.1% with placebo (geometric mean between-group difference, -36.1%; 95% CI, -44.6 to -26.4; p<0.001)
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Vanrafia is the first and only FDA-approved selective endothelin A receptor antagonist for proteinuria reduction in primary IgAN; the endothelin and angiotensin II receptor antagonist sparsentan (Filspari) is indicated to slow kidney function decline in adults with primary IgAN who are at risk for disease progression but carries a boxed warning for hepatotoxicity and embryo-fetal toxicity; budesonide (Tarpeyo), a corticosteroid, is similarly indicated to reduce the loss of kidney function in adults with primary IgAN who are at risk for disease progression and has a recommended duration of therapy of nine months; iptacopan (Fabhalta) is a complement factor B inhibitor that has Accelerated Approval for the same indication as Vanrafia but carries a boxed warning for serious infections caused by encapsulated bacteria
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Boxed warning for embryo-fetal toxicity
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Product is available from Novartis with an AWP of $534.25 per tablet
April 23, 2025 – penpulimab-kcqx (no trade name)
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Biologics License Application (BLA) approval; Assessment Aid, Breakthrough Therapy, Fast Track, Orphan Drug
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Programmed death receptor-1 (PD-1)-blocking antibody
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Indicated (1) in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC); and (2) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
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Solution for injection: 100 mg/10 mL (10 mg/mL) in a single-dose vial
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Recommended dosage is administered as an IV infusion every two or three weeks (depending on if used as a single agent or with other agents) until disease progression or a maximum of 24 months
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Approval was based on results from two studies: a randomized, double-blind, Phase 3 trial, AK105-304 (n=291) in which patients received penpulimab or placebo in combination with cisplatin or carboplatin and gemcitabine, and an open-label, single-arm, non-U.S. (conducted in China) study, AK105-202 (n=125); in AK105-304, progression-free survival (PFS) was significantly improved in patients in the penpulimab study group (median PFS, 9.6 months) compared to those in the placebo group (median PFS, 7 months) with a hazard ratio of 0.45 (95% CI, 0.33 to 0.62); in study AK105-202, the objective response rate was 28% with the majority of those who responded exhibiting partial responses
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Toripalimab-tpzi (Loqtorzi) is also a PD-1-blocking antibody similarly indicated (1) in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced NPC; (2) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy
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Product will be available from Akeso with time frame to be determined (TBD) and pricing to follow
March 25, 2025 – tesamorelin (Egrifta WR)
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Supplemental Biologics License Application (sBLA) approval; Egrifta WR (F8 formulation) will replace the current F4 formulation (Egrifta SV); Egrifta WR is a daily injectable but only requires weekly reconstitution; it also requires less than half the administration volume of Egrifta SV, which requires daily reconstitution
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Growth hormone-releasing factor (GHRF) analog; the new concentrated F8 formulation has demonstrated bioequivalence to the original F1 formulation (previously sold as Egrifta)
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Indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy
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Limitations of use: (1) long-term cardiovascular safety has not been established; (2) not indicated for weight loss management; and (3) no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking Egrifta WR
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For injection: 11.6 mg of tesamorelin as a lyophilized powder in a single patient-use vial for reconstitution and a multiple-dose diluent of 30 mL of bacteriostatic water for injection; one reconstituted vial provides daily doses for seven days
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Recommended dosage is administered SC once daily into the abdomen by a patient or caregiver following proper training on reconstitution and administration
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Product will be available from Theratechnologies with time frame TBD and pricing to follow
March 25, 2025 – denosumab-bnht (Bomyntra)
- BLA approval; denosumab-bnht (Bomyntra) is a biosimilar to reference drug denosumab (Xgeva); fourth FDA-approved biosimilar to Xgeva (one of which is interchangeable)
- FDA also approved unbranded biologic product labeling for this product, denosumab-bnht; the label for the unbranded biologic states "This product is Bomyntra (denosumab-bnht). Denosumab-bnht is biosimilar to Xgeva (denosumab)"
- RANK ligand inhibitor
- Indicated for (1) prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; (2) treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and (3) treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (same indications as reference drug Xgeva)
- Solution for injection: 120 mg/1.7 mL in a single-dose vial (same as Xgeva) and in a single-dose prefilled syringe in the same strength
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Recommended dosage is administered every four weeks SC into the upper arm, upper thigh or abdomen by a health care professional (HCP); additional doses are given on days eight and 15 for the first month of therapy in patients being treated for giant cell tumor of bone or hypercalcemia of malignancy; calcium and vitamin D should be taken as needed to treat/prevent hypocalcemia
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Product will be available from Fresenius Kabi mid-2025 with pricing to follow
March 25, 2025 – denosumab-bnht (Conexxence)
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BLA approval; denosumab-bnht (Conexxence) is a biosimilar to reference drug denosumab (Prolia); fourth FDA-approved biosimilar to Prolia (one of which is interchangeable)
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FDA also approved unbranded biologic product labeling for this product, denosumab-bnht; the label for the unbranded biologic states "This product is Conexxence (denosumab-bnht). Denosumab-bnht is biosimilar to Prolia (denosumab)"
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RANK ligand inhibitor
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Indicated for the treatment (1) of postmenopausal women with osteoporosis at high risk for fracture; (2) to increase bone mass in men with osteoporosis at high risk for fracture; (3) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; (4) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and (5) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer (same indications as Prolia)
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Solution for injection: 60 mg/mL single-dose prefilled syringe (same as Prolia)
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Recommended dosage is given every six months as a SC injection in the upper arm, upper thigh or abdomen administered by an HCP; patients should take calcium and vitamin D daily
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Boxed warning for severe hypocalcemia in patients with advanced kidney disease and carries a Risk Evaluation and Mitigation Strategy (REMS)
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Product will be available from Fresenius Kabi mid-2025 with pricing to follow
April 7, 2025 – adalimumab-aaty (Yuflyma)
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sBLA approval; certain formulations of adalimumab-aaty (Yuflyma) have received FDA approval as an interchangeable biosimilar to adalimumab (Humira); previously, Yuflyma was only approved as a biosimilar to Humira; eighth FDA-approved interchangeable biosimilar to Humira; six other biosimilars are FDA-approved without interchangeability designation (or with only some strengths having interchangeability)
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Tumor necrosis factor (TNF) blocker
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Indicated for select patients with (1) moderately to severely active rheumatoid arthritis (RA) (adults); (2) moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) (≥ 2 years of age); (3) active psoriatic arthritis (PsA) (adults); (4) active ankylosing spondylitis (AS) (adults); (5) moderately to severely active Crohn’s disease (CD) (adults and pediatric patients ≥ 6 years of age); (6) moderately to severely active ulcerative colitis (UC) (adults only); (7) moderate to severe chronic plaque psoriasis (adults); (8) moderate to severe hidradenitis suppurativa (HS) (adults only); and (9) uveitis (non-infectious intermediate, posterior and panuveitis) (adults only); Humira is also indicated for pediatric patients ≥ 5 years of age with UC, pediatric patients ≥ 12 years of age with HS and pediatric patients ≥ 2 years of age with uveitis
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Solution for injection: 80 mg/0.8 mL prefilled syringe with safety guard and single-dose prefilled syringe; 20 mg/0.2 mL single-dose prefilled syringe (formulations designated as interchangeable)
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Recommended dosage is given SC and is based on indication, patient’s age (pediatric or adult) and body weight (for pediatric patients); can be administered by a patient or caregiver
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Boxed warning for serious infections and malignancy (same as Humira)
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Product is available from Celltrion with an AWP of $3,945.90 per each 20 mg/0.2 mL prefilled syringe and pricing of the 80 mg/0.8 mL prefilled syringes TBD
April 10, 2025 – bevacizumab-nwgd (Jobevne)
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BLA approval; bevacizumab-nwgd (Jobevne) is a biosimilar to reference drug bevacizumab (Avastin); sixth FDA-approved biosimilar to Avastin (none are interchangeable)
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Vascular endothelial growth factor (VEGF) inhibitor
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Indicated for (1) metastatic colorectal cancer (CRC), in combination with IV fluorouracil-based chemotherapy for first-or second-line treatment; (2) metastatic CRC, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen; (3) unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel for first-line treatment; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma (RCC) in combination with interferon alfa; (6) persistent, recurrent or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan; (7) epithelial ovarian, fallopian tube or primary peritoneal cancer – in combination with carboplatin and paclitaxel, followed by use as a single agent, for stage III or IV disease following initial surgical resection; in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens; and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease; Avastin is also indicated for select patients with hepatocellular carcinoma (HCC)
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Limitation of use: not indicated for adjuvant treatment of colon cancer
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Solution for injection: 100 mg/4 mL and 400 mg/16 mL in single-dose vials (same as Avastin)
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Recommended dosage is administered by an HCP as a weight-based IV infusion every two or three weeks depending on indication; duration of therapy is also dependent on indication and concurrent therapies
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Product will be available from Biocon with time frame TBD and pricing to follow
March 12, 2025 – fluocinolone acetonide intravitreal implant (Iluvien)
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Alimera; corticosteroid; supplemental NDA (sNDA) approved for consolidation of labeling of bioequivalent strengths of fluocinolone acetonide implants, Iluvien and fluocinolone acetonide intravitreal implant (Yutiq); product will be marketed under combined label later this year
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New indication: treatment of chronic non-infectious uveitis affecting the posterior segment of the eye
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Available as a non-bioerodable intravitreal implant in a drug delivery system containing fluocinolone acetonide released for up to 36 months; inserted under aseptic conditions as an ophthalmic intravitreal injection by an HCP
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Other indication: diabetic macular edema in select patients
March 26, 2025 – cabozantinib (Cabometyx)
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Exelixis; kinase inhibitor; Assessment Aid, Project Orbis
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New indication: for adult and pediatric patients ≥ 12 years of age with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET)
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Administered orally once daily with dosage based on patient age and body weight (e.g., adult and pediatric patients with body weight ≥ 40 kg, pediatric patients with body weight < 40 kg); therapy is continued until disease progression or unacceptable toxicity
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Other indications: select patients with RCC, HCC, thyroid cancer
March 27, 2025 – nedosiran (Rivfloza)
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Novo Nordisk; lactate dehydrogenase A (LDHA)-directed siRNA
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Expanded indication: lower urinary oxalate levels in children ≥ 2 years of age with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function (e.g., estimated glomerular filtration rate [eGFR] ≥ 30 mL/min/1.73 m²); previously, indicated only for this use in adults and children ≥ 9 years of age
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Administered as a SC once monthly injection into the abdomen or the upper thigh with dosage dependent on age (2 years of age to < 12 years of age, ≥ 12 years of age) and actual body weight (< 39 kg, 39 kg to < 50 kg, ≥ 50 kg); in pediatric patients 2 to < 12 years of age who weigh ≥ 39 kg, a caregiver may inject using the prefilled syringe
March 28, 2025 – durvalumab (Imfinzi)
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AstraZeneca; programmed death-ligand 1 (PD-L1) blocking antibody; Assessment Aid, Priority Review
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New indication: in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant treatment following radical cystectomy, for the treatment of adults with muscle invasive bladder cancer (MIBC)
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Administered as an IV infusion by an HCP with dosing dependent on patient body weight (≥ 30 kg or < 30 kg); for neoadjuvant treatment, given in combination with gemcitabine and cisplatin every three weeks for four cycles prior to surgery; for adjuvant treatment, given every four weeks as a single agent for up to eight cycles after surgery
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Other indications: select patients with NSCLC, limited-stage small cell lung cancer (LS-SCLC), extensive-stage small cell lung cancer (ES-SCLC), biliary tract cancer, HCC, endometrial cancer that is mismatch repair deficient (dMMR)
April 3, 2025 – inebilizumab-cdon (Uplizna)
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Amgen; cluster of differentiation (CD)19-directed cytolytic antibody; Breakthrough Therapy; first and only FDA-approved treatment for immunoglobulin G4-related disease (IgG4-RD)
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New indication: treatment of IgG4-RD in adult patients
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Administered as an IV infusion by an HCP titrated to completion over approximately 90 minutes; initial dose is followed two weeks later by a second dose; subsequent doses are started six months from the first infusion and are given every six months
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Other indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
April 8, 2025 – ipilimumab (Yervoy)
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Bristol-Myers Squibb; human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody; Assessment Aid, Breakthrough Therapy, Orphan Drug, Priority Review, Project Orbis
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Expanded indication: in combination with nivolumab (Opdivo) for the treatment of adults and pediatrics patients ≥ 12 years of age with unresectable or metastatic microsatellite instability-high (MSI-H) or dMMR CRC; previously, the CRC indication was an Accelerated Approval and only for adults and pediatric patients ≥ 12 years old with MSI-H or dMMR metastatic CRC that had progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan, in combination with Opdivo
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Administered as an IV infusion by an HCP as a weight-based dose for adults and pediatric patients immediately following nivolumab on the same day every three weeks for a maximum of four doses; following completion of the combination, Opdivo is administered as a single agent as recommended in the product labeling
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Other indications: select patients with melanoma, RCC, HCC, NSCLC, malignant pleural mesothelioma and esophageal cancer
April 8, 2025 – nivolumab (Opdivo)
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Bristol-Myers Squibb; PD-1-blocking antibody; Assessment Aid, Breakthrough Therapy, Orphan Drug, Priority Review, Project Orbis
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Expanded indication: in combination with ipilimumab (Yervoy) for the treatment of adults and pediatric patients ≥ 12 years of age with unresectable or metastatic MSI-H or dMMR CRC; previously, it was only indicated for CRC as an Accelerated Approval in adults and pediatric patients ≥ 12 years of age with MSI-H or dMMR metastatic CRC that had progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan, as a single agent or in combination with ipilimumab
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The Accelerated Approval was also converted to regular approval for single agent Opdivo for adult and pediatric patients ≥ 12 years of age with MSI-H or dMMR metastatic CRC that has progressed following fluoropyrimidine, oxaliplatin and irinotecan
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Administered by an HCP as an IV infusion of Opdivo followed by an IV infusion of Yervoy on the same day every three weeks for a maximum of four doses, then Opdivo every two weeks or every four weeks
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Other indications: select patients with melanoma, NSCLC, malignant pleural mesothelioma, RCC, classical Hodgkin lymphoma (cHL), squamous cell carcinoma of the head and heck (SCCHN), urothelial carcinoma, HCC, esophageal cancer, gastric cancer, gastroesophageal junction (GEJ) cancer and esophageal adenocarcinoma
April 11, 2025 – ipilimumab (Yervoy)
- Bristol-Myers Squibb; human CTLA-4-blocking antibody; Assessment Aid, Orphan Drug, Real-Time Oncology Review
- Expanded indication: in combination with nivolumab (Opdivo) for the first-line treatment of adults with unresectable or metastatic HCC; previously, the HCC indication was only for adults who had been previously treated with sorafenib (Accelerated Approval)
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Administered as an IV infusion by an HCP as a weight-based dose for adults and pediatric patients immediately following Opdivo on the same day every three weeks for a maximum of four doses; following completion of the combination, Opdivo is administered as a single agent as recommended in the product labeling
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Other indications: select patients with melanoma, RCC, HCC, NSCLC, malignant pleural mesothelioma and esophageal cancer
April 11, 2025 – nivolumab (Opdivo)
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Bristol-Myers Squibb; PD-1-blocking antibody; Assessment Aid, Orphan Drug, Real-Time Oncology Review
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Expanded indication: in combination with ipilimumab (Yervoy) for the first-line treatment of adults with unresectable or metastatic HCC; previously, the HCC indication was only for adults who had been previously treated with sorafenib (Accelerated Approval)
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Administered by an HCP as a weight-based IV infusion of Opdivo followed by weight-based Yervoy on the same day every three weeks for four doses, then fixed-dose Opdivo every two weeks or every four weeks
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Other indications: select patients with melanoma, NSCLC, malignant pleural mesothelioma, RCC, cHL, SCCHN, urothelial carcinoma, HCC, esophageal cancer, gastric cancer, GEJ cancer and esophageal adenocarcinoma
April 15, 2025 – osilodrostat (Isturisa)
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Recordati Rare Diseases; cortisol synthesis inhibitor
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Expanded indication: for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative; previously, indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative
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Administered orally twice daily, with or without food, and followed by titration no more frequently than every two weeks based on rate of cortisol changes, individual tolerability, and improvement in signs and symptoms
April 17, 2025 – dupilumab (Dupixent)
- Regeneron; interleukin-4 receptor alpha antagonist
- New indication: for the treatment of adult and pediatric patients ≥ 12 years of age with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment (not indicated for other forms of urticaria)
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Administered SC as a loading dose followed by maintenance dosing every two weeks; dosage is weight-based in pediatric patients (30 kg to <60 kg; ≥ 60 kg)
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Other indications: select patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease
Traditional
March 25, 2025 – gepotidacin (Blujepa)
- NDA approval; Priority Review
- Triazaacenaphthylene bacterial type II topoisomerase inhibitor
- Indicated for the treatment of female adult and pediatric patients ≥ 12 years of age weighing ≥ 40 kg with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis; Blujepa should only be used to treat infections proven or strongly suspected to be caused by bacteria
- Oral tablets: 750 mg
- Recommended dosage is two tablets orally twice daily for five days; Blujepa should be administered after a meal to reduce the possibility of gastrointestinal intolerance
- Approval was based on results from two randomized, controlled, double-blind, Phase 3, non-inferiority trials (EAGLE-2; n=1,531 and EAGLE-3; n=1,605) that evaluated therapeutic success and demonstrated non-inferiority to nitrofurantoin in both studies (EAGLE-2, 50.6% of gepotidacin patients versus 47% of nitrofurantoin patients; adjusted difference, 4.3%; 95% CI, -3.6 to 12.1) and superiority to nitrofurantoin in EAGLE-3 (58.5% of gepotidacin patients versus 43.6% of nitrofurantoin patients; adjusted difference, 14.6%; 95% CI, 6.4 to 22.8)
- First-in-class agent; expected to compete with other antibacterial therapies indicated for UTI (e.g., nitrofurantoin, sulfamethoxazole/trimethoprim, fluoroquinolones, fosfomycin, beta-lactams, pivmecillinam [Pivya])
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Product will be available from GlaxoSmithKline in the second half of 2025
None
March 21, 2025 – darunavir/cobicistat (Prezcobix)
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Janssen; two-drug combination of darunavir, a HIV-1 protease inhibitor, and cobicistat, a cytochrome (CYP) 3A inhibitor; new tablet strength of 675 mg darunavir/150 mg cobicistat also approved in conjunction with expanded pediatric population; previously, only approved as an oral tablet of 800 mg darunavir/150 mg cobicistat
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Expanded indication: to include pediatric patients weighing ≥ 25 kg to < 40 kg for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced patients with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V); previously, it was only indicated for use in this population for patients who were ≥ 40 kg
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Administered for pediatric patients weighing ≥ 25 kg to < 40 kg as one 675 mg/150 mg tablet taken orally once daily with food
April 4, 2025 – tedizolid (Sivextro)
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Cubist; oxazolidinone antibacterial
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Expanded indication: adult and adolescent indication for treatment of acute bacterial skin and skin structure infections (ABSSSI) expanded to include (1) pediatric patients < 12 years of age and weighing ≥ 35 kg for the oral formulation and (2) pediatric patients ≥ 26 weeks gestational age and weighing ≥ 1 kg for the IV formulation; previously, it was indicated for adult and pediatric patients ≥ 12 years of age for the treatment of ABSSSI caused by designated susceptible bacteria
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Administered as a weight-based dosage for the IV formulation and one tablet taken orally once daily for six days for pediatric patients ≥ 35 kg; the tablet formulation should not be administered to pediatric patients weighing < 35 kg
April 7, 2025 – dexamethasone ophthalmic insert (Dextenza)
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Ocular Therapeutix; corticosteroid
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Expanded indications: to include pediatric patients; indicated for (1) the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and (2) treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients ≥ 2 years of age (use is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure); previously, it was only indicated for use in adults
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Inserted by a trained HCP in the lower lacrimal punctum into the canaliculus; a single insert releases dexamethasone for up to 30 days following insertion (the insert is resorbable and does not require removal)
April 15, 2025 – diazepam nasal spray (Valtoco)
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Neurelis; benzodiazepine
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Expanded indication: to include pediatric patients with epilepsy ≥ 2 years of age for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (e.g., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern; previously, only indicated for patients with epilepsy ≥ 6 years of age
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Administered intranasally into one or both nostrils (depending on the dose) by a caregiver trained to identify seizure clusters and to use the product; dosage is based on the patient’s age and body weight; a second dose, if required, may be administered ≥ 4 hours after the initial dose
First generic drug launches
March 28, 2025 – finasteride/tadalafil capsule (Entadfi)
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Novitium/Ani launched a generic to Blue Water’s Entadfi
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Combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor; indicated to initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks
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Recommended dosage is one capsule orally once daily at approximately the same time every day
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Annual sales for Entadfi in 2024 are TBD
HIV human immunodeficiency virus
RANK receptor activator of nuclear factor κB
RNA ribonucleic acid
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