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Eylea Apprved in Japan

Newest market after U.S., EC

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Regeneron Pharmaceuticals‘ Eylea (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO) from the Japanese Ministry of Health, Labour and Welfare (MHLW).

Eylea was approved in the U.S. 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 2012. Eylea has also been approved in the European Union (EU), Japan, Australia, and in several other countries for use in wet AMD. Eylea has also been approved by the European Commission for the treatment of visual impairment due to macular edema following CRVO, as well as in selected countries in Asia and Latin America. Regulatory submissions have also been made in the U.S. and the EU for Eylea in Diabetic Macular Edema.

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the U.S. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a royalty on net sales.

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