Bayer files for EMA approval of Eylea for macular edema secondary to BRVO

11 June 2014

German pharma major Bayer (BAYN: DE) has submitted an application to the European Medicines Agency seeking marketing authorization in the European Union for Eylea (aflibercept) injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).

The drug is under development with US biotech Regeneron Pharmaceuticals (Nasdaq: REGN), which licensed Bayer HealthCare the exclusive marketing rights outside the USA, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales. Regeneron’s sales of the drug in 2013 were up 68% to $1.41 billion. Eylea generated 333 million euros ($454 million) of revenue for Bayer in 2013, with 126 million euros coming in the last quarter.

Clinical backing for submission

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