Regeneron EYLEA Application for Diabetic Retinopathy Accepted for FDA Review

 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the EYLEA® (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.

DR is the leading cause of blindness among working-age American adults, affecting more than 8 million people in the U.S. alone. In 2019, EYLEA was approved for the treatment of all stages of DR with a dosing regimen of every 4 or 8 weeks after five initial monthly doses. If approved, the 16-week dosing regimen could offer certain patients a potentially longer treatment interval and doctors with greater flexibility to individualize treatment.

The sBLA is supported by data from the Phase 3 PANORAMA trial investigating every 8- and 16-week EYLEA dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). The submission was further supported by data from the NIH-sponsored Protocol W trial investigating an EYLEA every 16-week dosing regimen in patients with moderate to severe NPDR without center-involved DME versus sham.

https://finance.yahoo.com/news/eylea-aflibercept-injection-sbla-every-113000197.html