Regeneron/Bayer Eylea filed for marketing authorization in Japan for macular edema

4 September 2014

American biotech company Regeneron (Nasdaq: REGN)’s global development partner for Eylea (aflibercept), Germany's Bayer (BAYN: DE), has submitted a marketing authorization application for the drug to treat macular edema following branch retinal vein occlusion to the Japanese Ministry of Health, Labor and Welfare.

Eylea is licensed to Bayer’s Japanese subsidiary, Bayer Yakuhin, and has already been approved for patients with neovascular age-related macular degeneration and macular edema secondary to central retinal vein occlusion in Japan. Japanese marketing authorization applications have been submitted for the treatment of choroidal neovascularization secondary to pathologic myopia and for the treatment of diabetic macular edema.

The drug achieved global sales ifor Bayer of around $260 million in the second quarter of 2014 for the two currently-approved indications.

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