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Monday, 12/01/2014 7:06:52 AM

Monday, December 01, 2014 7:06:52 AM

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Regeneron announced FDA accepted review for sBLA for EYLEA injection
Regeneron announced that the FDA has accepted for priority review the supplemental biologics license application for EYLEA Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema. Under the Prescription Drug User Fee Act, the goal for a priority review is six months, for a target action date of March 30, 2015. In September 2014, the FDA granted EYLEA 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. The Phase 3 VIVID-DME and VISTA-DME trials, which supported the approval of EYLEA in DME, included a pre-specified secondary endpoint evaluating diabetic retinopathy based on an established grading scale in patients with DME. The two-year results from these trials on the primary endpoint of best-corrected visual acuity and overall safety have been previously reported

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