Posted by Michael Wonder on 12 Dec 2017
Regeneron announces FDA acceptance of sBLA filing for 12 week dosing of Eylea (aflibercept) injection for patients with wet AMD
11 December 2017 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the Company's supplemental biologics license application for a 12-week dosing interval of Eylea (aflibercept) injection for the treatment of patients with wet age-related degeneration (wet AMD) based on physician's assessment.
Under the Prescription Drug User Fee Act, the goal for a standard review of an sBLA is ten months from submission for a target action date of 11 August 2018.
The submission is based on an integrated analysis of two-year results from VIEW 1 and VIEW 2 - two pivotal, randomised, double-masked, Phase 3 trials that investigated the treatment of EYLEA in patients with wet AMD.
