Unanimous FDA advisory support for Regeneron wet-AMD drug Eylea/VEGF Trap-Eye

As was largely expected following positive briefing papers from the US Food and Drug Administration earlier in the week, on Friday, the FDA’s the Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend that the agency approves Regeneron Pharmaceuticals’ (Nasdaq: REGN) Eylea (aflibercept ophthalmic solution), also known as VEGF Trap-Eye.

The drug, under development with Germany’s Bayer (BAY: DE), should be cleared for the treatment of the neovascular form of age-related macular degeneration (wet AMD) at a dose of 2mg every eight weeks, following three initial doses given every four weeks.

Bayer HealthCare will market VEGF Trap-Eye outside the USA, where the companies will share equally the profits from any future sales of the drug. Regeneron maintains exclusive rights in the USA. Bayer submitted an application for marketing authorization in Europe in wet AMD earlier this month (The Pharma Letter June 7). Aflibercept is also licensed to France’s Sanofi, which is developing the drug under the trade name Zaltrap for metastatic colon cancer.