Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of Eylea (aflibercept) for Patients with Wet AMD
Regeneron announced that the FDA has accepted for review the company's supplemental Biologics License Application for a 12-week dosing interval of Eylea (aflibercept) injection in patients with wet age-related macular degeneration (AMD) based on physician's assessment. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is 10 months from submission for a target action date of August 11, 2018.
For wet AMD, the current recommended dose for Eylea is 2 mg administered by injection in the eye every 2 months (8 weeks) following three initial monthly (every 4 weeks) injections. Eylea may also be dosed once per month.
"Eylea is a cornerstone treatment approved for many retinal diseases, and we remain committed to advancing new research to optimize its use and extend its benefits to other retinal diseases and patient populations," George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said in a company news release.
The sBLA submission is based on an integrated analysis of 2-year results from VIEW 1 and VIEW 2 – two pivotal, randomized, double-masked, phase 3 trials that investigated the treatment of Eylea in patients with wet AMD. The integrated analysis found that 51 percent of study patients had their Eylea dosing interval extended to every 12 weeks at the beginning of the second year (week 52) of treatment, based on an evaluate and extend approach, and were able to maintain this every 12-week dosing interval and their best-corrected visual acuity (BCVA) gains when they were assessed at the end of the second year (week 96). No new safety signals were identified. Criteria for patients to receive Eylea on a 12-week dosing interval included having no evidence of new or progressive wet AMD as determined by anatomic and visual measures.
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