Regeneron files Eylea for DME indication
Regeneron announced today that the FDA has accepted Eylea's supplemental Biologics License Application for the treatment of diabetic macular edema (DME). The goal for a standard review of an sBLA is 10 months from submission, for a target action date of August 18, 2014. The submission is based off positive results from the company's Phase 3 VIVID and VISTA trials.
Eylea was approved in the US for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2011. Bayer and Regeneron are collaborating on the global development of the drug. Regeneron holds exclusive rights in the US, while Bayer has exclusive marketing rights ex-US. Both companies will share equal profits from sales of Eylea except for Japan, where Regeneron receives a royalty.