Eylea label expansion application submitted to EMA


Regeneron Pharmaceuticals (REGN) reports that collaboration partner Bayer HealthCare (BAYZF) (BAYRY) has submitted an application to the EMA for marketing authorization in the European Union for Eylea (aflibercept) for the treatment of macular edema following branch retinal vein occlusion (BRVO).

The U.S. FDA approved the drug for the treatment of wet Age-related Macular Degeneration (AMD) in November 2011 and for Central Retinal Vein Occlusion (CRVO) in September 2012. The EMA has also approved Eylea for wet AMD and Macular Edema following CRVO.

Regulatory submissions have been made to the FDA for Macular Edema following BRVO  and in the EU for Diabetic Macular Edema.

Regeneron has exclusive rights to Eylea in the U.S. Bayer HealthCare has exclusive marketing rights ex-U.S. (the companies equally share the profits). In Japan, Regeneron receives a percentage of sales.

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