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The FDA has accepted for priority review Regeneron Pharmaceuticals’ supplemental biologics license application for aflibercept (Eylea) injection, a treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
Terrytown, NY-The FDA has accepted for priority review Regeneron Pharmaceuticals’ supplemental biologics license application for aflibercept (Eylea) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
Under the Prescription Drug User Fee Act, the goal for a priority review is 6 months, for a target action date of March 30, 2015.
In September, the FDA granted the injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with DME. The FDA created the Breakthrough Therapy designation to expedite the development and review of drugs for serious or life-threatening conditions.
A Breakthrough Therapy drug must show preliminary clinical evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy.
"Diabetic retinopathy coupled with DME is a significant threat to vision for people with diabetes," said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. "Regeneron looks forward to working with the FDA to help address this significant treatment gap in a leading cause of blindness in working-age adults."
The phase III VIVID-DME and VISTA-DME trials-which supported the approval of the treatment in DME-included a pre-specified secondary endpoint evaluating diabetic retinopathy based on an established grading scale in patients with DME. The 2-year results from these trials on the primary endpoint of best-corrected visual acuity and overall safety have been previously reported.
The injection is available as a single, 2 mg strength intravitreal injection for all approved indications. The treatment is approved in the United States for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion, and DME.