Regeneron Pharmaceuticals, Inc.,a leading biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review the company's supplemental Biologics License Application (sBLA) for a 12-week dosing interval of Eylea (aflibercept) injection in patients with wet age-related macular degeneration (wet AMD) based on physician's assessment.
Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten 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 two months (eight weeks) following three initial monthly (every four 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," said George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer of Regeneron.
The sBLA submission is based on an integrated analysis of two-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.
Eylea (aflibercept) injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. Eylea is supported by a robust body of research that includes seven pivotal phase 3 studies.
Eylea (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
Wet Age-related Macular Degeneration (AMD): The recommended dose for Eylea is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. Eylea may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for Eylea is 2 mg administered by injection in the eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for Eylea is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. Eylea may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Us fda accepts regeneron\'s sbla filing, eylea injection for patients with wet amd
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