Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration or FDA has accepted for standard review the Company's supplemental Biologics License Application or sBLA for EYLEA (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion or BRVO.
Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of October 23, 2014.
The company stated that EYLEA sBLA submission in this indication was based on the positive results from the Phase 3 VIBRANT trial, which was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion.
EYLEA was approved in the United States 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) and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in the U.S. and the EU for EYLEA for the treatment of Diabetic Macular Edema.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. 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 percentage of net sales.
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