Traditional Drug Pipeline Update: May 2022

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

• Triumeq PD™ (abacavir sulfate; dolutegravir sodium; lamivudine fixed dose combination tablet): The Food and Drug Administration (FDA) has approved ViiV Healthcare’s new drug application (NDA) for Triumeq PD, a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10 kilograms to <25 kilograms with human immunodeficiency virus type 1 (HIV-1).¹ The approval of Triumeq PD was based on the results of a Phase 4 trial evaluating the use of ViiV Healthcare’s Epzicom^® (abacavir and lamivudine) in pediatric patients.² Additionally, approval was also supported based on the results of a Phase 1/2 trial supporting the use of ViiV Healthcare’s Tivicay^® (dolutegravir) in pediatric patients.² Triumeq PD has launched with a wholesale acquisition cost (WAC) of $1,002 for 90 tablets. In addition to approval of Triumeq PD, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine to 25 kilograms from 40 kilograms.¹
• Glycopyrrolate™ (glycopyrrolate injection for intramuscular or intravenous use): Fresenius Kabi USA received FDA approval for Glycopyrrolate 0.6mg/3mL injection for use in adult and pediatric patients undergoing anesthesia and in adults with peptic ulcers.³ In anesthesia, Glycopyrrolate injection is indicated for reduction of airway or gastric secretions, and volume and acidity of gastric sections, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, for use intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrythmias, and for protection against peripheral muscarinic effects of cholinergic agents. The product is also indicated to be used as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.³ Glycopyrrolate injection was approved through the 505(b)(2) pathway using Baxter Healthcare’s Robinul^® injection (glycopyrrolate) as its reference product.³ Glycopyrrolate is available generically as an oral solution, tablet, inhaled solution, and injection at various strengths.⁴ Pricing and launch information have not been released.
• Epsolay™ (benzoyl peroxide, topical cream) 5%: The FDA approved Epsolay, Sol-Gel Technologies’ topical cream treatment for the treatment of inflammatory lesions of rosacea in adults.⁵ Epsolay is encapsulated within silica-based patented microcapsules to create a barrier between the medication and the skin.⁶ The silica-based shell is designed to slowly release benzoyl peroxide 5% over time to provide a favorable efficacy and safety profile.⁶ The approval of Epsolay is supported by data from two positive, identical Phase 3 randomized, double-blind, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in people with inflammatory lesions of rosacea.^5,6 The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. Epsolay was more effective than vehicle cream on the co-primary efficacy endpoints starting from four weeks of treatment in both trials.^5,6 With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials compared to 38-46% with vehicle.^5,6 Nearly 50% of subjects were ‘clear’ (IGA=0) or ‘almost clear’ (IGA=1) at 12 weeks vs. 38-46% with placebo.^5,6 Epsolay was approved through the 505(b)(2) pathway and has launched with a WAC of $475 per 30 grams.
• Vivjoa™ (oteseconazole, oral capsule): Mycovia Pharmaceuticals’ received FDA approval for Vivjoa for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential.⁷ Vivjoa is the first FDA-approved medication for RVVC; however, fluconazole is used off-label. The approval of Vivjoa is supported by the positive results from three Phase 3 trials of Vivjoa– two global, pivotal VIOLET studies and one U.S.-focused ultraVIOLET study.⁸ In the two global VIOLET studies, 93.3% and 96.1% of women with RVVC who received Vivjoa did not have a recurrence for the 48-week maintenance period compared to 57.2% and 60.6% of patients who received placebo.⁹ In the ultraVIOLET study, 89.7% of women with RVVC who received Vivjoa cleared their initial yeast infection and did not have a recurrence for the 50-week maintenance period compared to 57.1% of those who received fluconazole followed by placebo.⁹ Vivjoa launch and pricing is expected in the second quarter of 2022.
• Ermeza™ (levothyroxine sodium, oral solution): The FDA approved Mylan and Viatris’ NDA for Ermeza for the treatment of hypothyroidism and pituitary thyrotropin suppression in adults and pediatric patients, including neonates. Ermeza will be available as a 150 mcg/5 mL oral solution.¹⁰ Levothyroxine sodium oral solution is available as Thyquidity^® and Tirosint-Sol^® at various strengths. Pricing and launch information are pending.
• Voquezna Dual Pack™ and Voquezna Triple Pak™ (amoxicillin and vonoprazan, oral capsule and tablet; amoxicillin, clarithromycin, and vonoprazan, oral capsule and tablet): The FDA approved Phanthom Pharmaceuticals’ Voquezna Dual Pak and Triple Pak for the treatment of pylori infection in adults. The efficacy of Voquezna Triple Pak and Dual Pak were established in a randomized, controlled, double-blind triple therapy/open-label dual therapy study in treatment-naïve H. pylori-positive adult patients. Patients were randomized to Voquezna Triple Pak, Voquezna Dual Pak, or a proton pump inhibitor (PPI) (lansoprazole) plus amoxicillin plus clarithromycin (LAC) administered for 14 consecutive days. The primary endpoint was eradication rates of H. pylori at test-of-cure (≥ 27 days post-therapy). Voquezna Triple Pak and Voquezna Dual Pak were shown to be noninferior to LAC in patients who did not have a clarithromycin or amoxicillin resistant strain of H. pylori at baseline (eradication rates: 84.7%, 78.5%, and 78.8%, respectively).^11,12 Voquezna Triple Pak and Voquezna Dual Pak were shown to be superior to LAC in patients who had a clarithromycin resistant strain of H. pylori at baseline (eradication rates: 65.8%, 69.6%, and 31.9%, respectively) and in the overall population (eradication rates: 80.8%, 77.2%, and 68.5%, respectively).^11,12 U.S. commercial launch of Voquezna Dual Pak is expected in the third quarter of 2022 with pricing to follow.
• Mounjaro™ (tirzepatide, subcutaneous injection): Eli Lilly received FDA approval for Mounjaro, a new once weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on results from the Phase 3 SURPASS program, which included active comparators of injectable semaglutide 1mg, insulin glargine and insulin degludec.^13,14 Efficacy was evaluated for Mounjaro 5mg, 10mg and 15mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5mg and between 1.7% and 2.4% for both Mounjaro 10mg and Mounjaro15 mg.^13,14 Pricing and launch information have not been released.

Generic Drug Information

• Bidil^® (isosorbide dinitrate-hydralazine): Ricon Pharma launched its generic version of Arbor Pharmaceuticals’ Bidil for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. Ricon Pharma has been granted 180-day marketing exclusivity. Bidil generated $31 million in U.S. annual sales in 2021.
• Vimpat^® (lacosamide) 200mg/ 20 mL IV injection: Indoco Remedies launched its generic version of UCB’s Vimpat 200mg/20 mL IV injection indicated as monotherapy or adjunctive therapy in certain patients with partial-onset seizures and as adjunctive therapy in certain patients with primary generalized tonic-clonic seizures. Vimpat injection is indicated as a short-term replacement when oral administration is not feasible. Vimpat 200mg/20 mL IV injection generated $68 million in U.S. annual sales in 2021.
• Chantix^® (varenicline) starting month pack: Par Pharmaceuticals launched its generic version of Pfizer’s Chantix starting month pack with more manufacturers set to follow. Chantix starting month pack is indicated for the treatment of smoking cessation. The first Chantix generic was available in September 2021.
• Prexxartan^® (valsartan) 4 mg/mL oral solution: Lifsa Drugs launched its generic version of Carmel Biosciences and Medicure’s Prexxartan 4mg/mL oral solution. Prexxartan is indicated for the treatment of hypertension in adults and children six years and older, for the treatment of heart failure (NYHA class II-IV) to reduce the risk of hospitalization for heart failure and is indicated to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction. Prexxartan was voluntarily withdrawn from the market in September 2020 for reasons unrelated to safety or efficacy, as determined by the FDA.¹⁵ This determination allowed the FDA to approve abbreviated new drug applications (ANDAs) for valsartan oral solution.¹⁵
• Velcade^®+ (bortezomib) 3.5mg injection: Multiple manufacturers have launched their generic versions of Takeda’s Velcade (bortezomib) 3.5mg injection with more manufacturers scheduled to follow. Velcade is indicated for the treatment of adults with multiple myeloma or mantle cell lymphoma. Velcade generated $1,424 million in U.S. annual sales in 2021.
• Esbriet^®+ (pirfenidone): Sandoz launched an AB-rated generic version of Genentech’s Esbriet tablets with multiple manufacturers set to follow. Esbriet is approved for the treatment of idiopathic pulmonary fibrosis. Esbriet generated $867 million in U.S. annual sales in 2021.

+Specialty medication

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References

1. https://www.drugs.com/newdrugs/viiv-healthcare-announces-us-fda-approval-triumeq-pd-first-dispersible-single-tablet-regimen-5814.html
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214919s000lbl.pdf
4. https://www.micromedexsolutions.com/micromedex2/librarian/PFDefaultActionId/evidencexpert.DoIntegratedSearch?navitem=topHome&isToolPage=true#
5. https://ml.globenewswire.com/Resource/Download/c90c6cab-73f1-4f49-a08a-83bbf291a415
6. https://ir.sol-gel.com/news-releases/news-release-details/sol-gel-technologies-and-galderma-announce-fda-approval-epsolayr
7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215888s000lbl.pdf
8. https://www.uptodate.com/contents/candida-vulvovaginitis-treatment?search=recurrent%20vulvovaginal%20candidiasis%20treatment&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1
9. https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf
10. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215809s000lbl.pdf\
11. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215152s000,215153s000lbl.pdf
12. https://www.globenewswire.com/news-release/2022/05/03/2435147/0/en/Phathom-Pharmaceuticals-Announces-FDA-Approval-of-VOQUEZNA-TRIPLE-PAK-vonoprazan-amoxicillin-clarithromycin-and-VOQUEZNA-DUAL-PAK-vonoprazan-amoxicillin-for-the-Treatment-of-H-pylo.html
13. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf
14. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and
15. https://www.federalregister.gov/documents/2020/09/23/2020-20965/determination-that-prexxartan-valsartan-oral-solution-20-milligrams5-milliliters-and-80-milligrams20