FDA to Review Eylea for the Treatment of Non-Proliferative Diabetic Retinopathy
The FDA has set a target action date for the sBLA of May 13, 2019.
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) of Eylea (aflibercept; Regeneron) for the treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME).
Eylea is a vascular endothelial growth factor (VEGF) inhibitor administered as an intravitreal injection. It is currently indicated for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and diabetic retinopathy in patients with DME.
The sBLA includes results from the Phase 3 PANORAMA trial, which enrolled 402 patients with NPDR. Results at week 24 showed more than half of patients who received Eylea experienced a 2-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale vs patients who received a sham injection (58% vs 6%; P<.0001). No new safety signals were observed in the trial. One- year results from the trial are expected later this year.
The FDA has set a Prescription Drug User Fee Act target date of May 13, 2019 for the sBLA.
For more information visit Regeneron.com.