Bayer submits marketing authorization for Eylea in Japan

US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and partner Bayer’s (BAYN: DE) Japanese subsidiary Bayer Yakuhin have submitted an application for marketing authorization for Eylea (aflibercept) injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labor and Welfare (MHLW).

Eylea, which was approved in the USA 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, generated sales of $1.01 billion for Regeneron in the first nine months of 2103 and the company projected that, for the full year, revenues would come in at between $1.35 billion and $1.375 billion (The Pharma Letter November 6, 2013). Bayer has rights to the product outside the USA.

George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, said: “Clinically significant DME is a leading cause of vision loss in the working-age population suffering from diabetes. With increasing rates of diabetes worldwide, there continues to be a need for new treatment options. We are pleased with this regulatory submission and hope that if approved, Eylea will provide a new option for the treatment of DME in Japan.”