Traditional Drug Pipeline Update: February 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 articles for pipeline information on specialty drugs.

New Drug Information

• Brenzavvy^® (bexagliflozin): The U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Brenzavvyis indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Brenzavvy is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.  Brenzavvy was approved based on the Phase 3 studies that demonstrated that Brenzavvy significantly reduced hemoglobin A1C and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these agents.¹ Brenzavvy treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m². Brenzavvy is contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis. Brenzavvy will be available as 20mg oral tablets recommended to be taken once daily, in the morning with or without food; launch and price are pending.

Generic Drug Information

• Adrenalin^® inj, 1mg/mL (epinephrine inj, 1 mg/mL): International Medication Systems/Amphastar launched their generic version of Par Sterile Products’ Adrenalin for emergency treatment of allergic reactions, including anaphylaxis. Adrenalin generated $146 million U.S. annual sales in 2022.
• Latuda^® (lurasidone tab, 20mg, 40mg, 60mg, 80mg, 120mg): Ascend Laboratories has launched their generic version of Sunovion Pharmaceuticals’ Latuda indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate. Multiple manufacturers are scheduled to launch this year. Latuda generated $4,323 million in U.S. annual sales in 2021.

Reference

1. https://www.businesswire.com/news/home/20230123005126/en/TheracosBio-Announces-FDA-Approval-of-Brenzavvy%E2%84%A2-bexagliflozin-for-the-Treatment-of-Adults-with-Type-2-Diabetes

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