FDA accepts Eylea sBLA

Tarrytown, NY-The FDA has accepted for standard review Regeneron Pharmaceuticals Inc.’s supplemental Biologics License Application (sBLA) of aflibercept (Eylea) for the treatment of diabetic macular edema (DME).

Under the Prescription Drug User Fee Act, the goal for a standard review of an sBLA is 10 months from submission, for a target action date of August 2014.

“Diabetes is a growing public health concern and DME is a leading cause of vision loss in patients with diabetic retinopathy,” said George D. Yancopoulos, MD, PhD, chief scientific officer for Regeneron and president of Regeneron Laboratories. “We hope to be able to offer a new treatment option to patients who suffer from DME.”

The aflibercept sBLA submission is based on positive results from phase III VIVID and VISTA trials.

The drug 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.

The drug has also been approved in the European Union, Japan, Australia, and in several other countries for use in wet AMD, as well as by the European Commission and selected countries in Asia and Latin America for the treatment of visual impairment due to macular edema following CRVO.

Regulatory submissions have also been made in the European United for the drug in DME.

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