Posted by Michael Wonder on 29 Jun 2022
Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved every 4 and 8 week dosing regimens
Regeneron Pharmaceuticals today announced the U.S. FDA has accepted for review the Eylea (aflibercept) Injection supplemental biologics license application for an every 16 week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy.
The target action date for the FDA decision is 28 February 2023.
