Eylea filed for EU and US approval in diabetic macular edema

US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) says its partner German drug major Bayer (BAYN: DE) has submitted an application for marketing authorization in the European Union for Eylea (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME).

Regeneron, which retains product rights to the US market, has itself submitted a supplemental Biologics License Application (BLA) for Eylea in this indication to the US Food and Drug Administration.

"Diabetes is a growing, worldwide health concern and DME is a major cause of vision loss in those with diabetic retinopathy," said George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "We are pleased with this regulatory submission in a third indication for Eylea in Europe and, if approved, hope to be able to offer physicians and patients a new treatment option."