FDA committee backs Regeneron’s wet AMD drug


Takes Eylea a step closer to approval in the US

The Dermatologic and Ophthalmic Drugs Advisory Committee of the US FDA has unanimously backed Regeneron’s eye drug Eylea, which takes the drug a step closer to being approved by the US regulator.

Eylea (aflibercept ophthalmic solution), which is also known as VEGF Trap-Eye, has been backed 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.

The EYLEA wet AMD regulatory submissions are based on positive results from two Phase 3 trials.

The drug is under development with Bayer, which last month submitted an application for marketing authorisation in Europe in wet AMD. The German firm will market Eylea outside the US, where it will share the profits from any future sales equally with Regeneron.

‘The positive recommendation by the advisory committee is an important step toward providing wet AMD patients with a new treatment option that could potentially reduce the burden that exists with current therapies,’ said George Yancopoulos, president of Regeneron Research Laboratories.