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Eylea sBLA Accepted for Standard Review

Followup application covers DME indication

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Regeneron Pharmaceuticals‘ sBLA for Eylea has been accepted for standard review by the FDA. The sBLA is for the treatment of Diabetic Macular Edema (DME). The Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is 10 months from submission, for a target action date of August 18, 2014.

The Eylea sBLA submission is based on the positive results from the Phase III VIVID and VISTA trials. 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 EU, Japan, Australia, and in several other countries for use in wet AMD.

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the U.S.

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