FDA Grants Priority Review to Regeneron’s Higher-Dose Aflibercept BLA

The FDA has granted priority review to Regeneron Pharmaceuticals’ biologics license application (BLA) for aflibercept 8 mg in treating patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

The BLA is supported by data from two clinical trials, showing noninferiority to Regeneron’s Eylea (aflibercept) injection.

The company used a priority review voucher to gain a faster review by the FDA. The agency’s target action date is June 27.