US FDA schedules advisory meeting VEGF Trap-Eye from Regeneron, Bayer; latter debuts Advanced Aspirin

USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) and partner German drug major Bayer (BAY: DE) say the US Food and Drug Administration has scheduled a Dermatologic and Ophthalmic Drugs Advisory Committee Meeting to be held on June 17, 2011 to discuss the companies’ Biologics License Application for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

Under Section 505 of the Federal Food, Drug, and Cosmetic Act, absent special circumstances, all new chemical entities, such as VEGF Trap-Eye, are referred to an advisory committee for review. Regeneron submitted a BLA for marketing approval in wet AMD in the USA in February 2011 and received a Priority Review designation (The Pharma Letter April 19). Under priority review, the target date for an FDA decision on the BLA is August 20, 2011.

Bayer holds marketing rights to the product ex-USA, and VEGF Trap Eye is expected to be a significant growth driver for the company, along with its anticoagulant Xarelto (direct factor Xa inhibitor), which is anticipating expanded approval from the FDA, and liver and kidney cancer drug Nexavar (sorafenib).