Traditional Drug Pipeline Update: May 2023

This monthly pipeline wrap-up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

See separate article for pipeline information on specialty drugs.

New Drug Information

• Uzedy^® (risperidone extended-release injectable suspension): The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceuticals & MedinCell’s Uzedy for the treatment of schizophrenia in adults. Uzedy is a long-acting formulation that has flexible one- and two-month dosing intervals. Uzedy was approved via the 505(b)(2) pathway using Janssen’s Risperdal^®(risperidone) as its reference product. It is supplied in a kit containing a single-dose prefilled syringe and needle.¹ Uzedy is administered by a health care professional as an abdominal or upper arm SC injection. Uzedy has launched with the wholesale acquisition cost (WAC) ranging from $1,232 to $3,080 per month depending on dosage strength.
• Abilify Asimtufii^®(aripiprazole): The FDA has approved Otsuka and Lundbeck’s Abilify Asimtufii injectable suspension for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults. It is administered by a health care professional once every two months via intramuscular injection in the gluteal muscle.² Abilify Asimtufii was approved via the 505(b)(2) pathway using Otsuka’s Abilify Maintena™ (aripiprazole) as its reference product. Abilify Asimtufii has launched with an average wholesale price (AWP) of $4,894-6,526 per syringe.
• MydCombi^® (phenylephrine and tropicamide) ophthalmic solution: The FDA has approved Eyenovia’s Mydcombi 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. MydCombi is administered in the eye care practitioner’s office. MydCombi’s application is supported by data from two Phase 3 studies, MIST-1 and MIST-2 that evaluated the efficacy and safety of MydCombi. Findings from both studies demonstrated that approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation.³ MydCombi is seeking approval via the 505(b)2 pathway using tropicamide as its reference product. MydCombi launch and price are pending.
• Veozah^® (fezolinetant): The FDA approved Astellas Pharma’s Veozah 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Veozah is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. Veozah is a once daily oral tablet. The approval is based on the three Phase 3 clinical trials, SKYLIGHT 1 and SKLYLIGHT 2 that demonstrated safety and efficacy, while SKYLIGHT 4 was a safety study to characterize the long-term safety profile.⁴ Veozah has launched with a WAC of $550 for a 30-day supply. The WAC price is substantially higher than the $2,000 to $2,500 per year price that the Institute for Clinical and Economic Review (ICER) determined would be cost effective for the drug in an evaluation last year.⁵
• Miebo^™(perfluorohexyloctane ophthalmic solution; formerly known as NOV03): The FDA has approved Bausch + Lomb’s Miebo for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first FDA-approved treatment for DED that directly targets tear evaporation. Miebo’s approval was based on the two Phase 3 trials, GOBI and MOJAVE which measured change from baseline at week eight in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Both primary endpoints were met by demonstrating that patients experienced relief of symptoms as early as day 15 and through day 57 with a statistically significant reduction in VAS eye dryness score as well as a significant reduction in tCFS favoring Miebo.⁶ Launch and price are pending.
• Opvee^™ (nalmefene hydrochloride): The FDA has approved Opiant Pharmaceuticals’ Opvee nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use. Opvee was approved via the 505(b)(2) pathway using Otsuka Pharmaceutical Co.’s Selincro^® (nalmefene) as its reference product.⁷ Opvee launch and price are pending.
• Brixadi^™ (buprenorphine depot): Braeburn Pharmaceutical’s Brixadi has been approved for treatment for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support. Brixadi is to be administered only by health care providers in a health care setting. Brixadi was approved based on the Phase 3 efficacy and safety trial, that demonstrated weekly and monthly Brixadi met the primary endpoint of non-inferiority for responder rate compared to daily sublingual buprenorphine/naloxone 16.9% vs. 14.0%, respectively.⁸Brixadi will be available in the U.S. in September 2023 with pricing to follow.
• Xacduro^®(sulbactam for injection; durlobactam for injection): The FDA has approved Innoviva Specialty Therapeutics’ Xacduro, co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Xacduro’s approval was based on the Phase 3 ATTACK trial that demonstrated Xacduro was statistical non-inferiority compared to colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates (19% vs 32.3% respectively).⁹ The FDA Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in support of approval based on a favorable benefit-risk assessment of Xacduro.¹⁰ Xacduro launch and price are pending.

Generic Drug Information

• Iressa^® (gefitinib)+: Qilu Pharmaceutical/Ingenus launched their generic version of AstraZeneca’s Iressa for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations as detected by an FDA-approved test. Iressa generated less than $10 million in U.S. annual sales in 2022.

+Specialty medication

New Indications for Non-Specialty

Brand Name	Generic Name	Manufacturer	Indication	Approval Date
Rexulti®	brexpiprazole	H. Lundbeck A/S; Otsuka	Dementia-related agitation	05/10/2023
Farxiga®	dapagliflozin propanediol	AstraZeneca	Heart failure	05/08/2023
Qulipta®	atogepant	Allergan; AbbVie	Certain forms of migraine	04/17/2023

1. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2023/Teva-and-MedinCell-Announce-FDA-Approval-of-UZEDY-risperidone-Extended-Release-Injectable-Suspension-a-Long-Acting-Subcutaneous-Atypical-Antipsychotic-Injection-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx
2. https://www.fiercepharma.com/pharma/otsuka-lundbeck-gain-fda-nod-longer-acting-version-schizophrenia-drug-abilify
3. https://www.ophthalmologytimes.com/view/eyenovia-announces-fda-approval-of-mydcombi-first-ophthalmic-spray-for-mydriasis
4. https://www.reuters.com/business/health care-pharmaceuticals/us-fda-approves-astellas-pharmas-therapy-menopause-related-symptoms-2023-05-12/
5. https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-fezolinetant-for-vasomotor-symptoms-associated-with-menopause/
6. https://www.ophthalmologytimes.com/view/bausch-lomb-novaliq-announce-fda-approval-of-perfluorohexyloctane-ophthalmic-solution-for-treatment-of-dry-eye-disease
7. https://www.prnewswire.com/news-releases/indivior-announces-us-food-and-drug-administration-approval-of-opvee-nalmefene-nasal-spray-an-opioid-overdose-rescue-medicine-for-natural-and-synthetic-opioids-like-fentanyl-301831447.
8. https://www.drugs.com/newdrugs/fda-approves-opvee-nalmefene-hydrochloride-nasal-reverse-opioid-overdose-6022.html
9. https://www.prnewswire.com/news-releases/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder-301832521.html#:~:text=PLYMOUTH%20MEETING%2C%20Pa.%2C%20May,OUD)%20in%20patients%20who%20have
10. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria
11. https://www.businesswire.com/news/home/20230417005846/en/Sulbactam-Durlobactam-Unanimously-Recommended-for-Approval-by-FDA-Advisory-Committee