Regeneron Pharmaceuticals, Inc. (REGN) Announces FDA Acceptance of sBLA Filing


Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA® (aflibercept) Injection for Patients with Wet AMD

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. 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.

About EYLEA® (afliberceptInjection
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 medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.

In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.

There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.

Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.

The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.

It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.

EYLEA is for prescription use only. For additional safety information, please talk to your doctor and visit to see the full Prescribing Information for EYLEA.


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