News Feature | February 26, 2014

FDA Accepts Bayer And Regeneron's EYLEA sBLA For Standard Review

Source: Outsourced Pharma

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) has accepted for standard review Bayer and Regeneron’s supplemental biologics license application (sBLA) for its EYLEA® (aflibercept) Injection.

George D. Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, said “We are pleased that the FDA has accepted the sBLA for EYLEA for the treatment of macular edema following BRVO, an important cause of vision loss... This is the fourth regulatory submission in the U.S. for EYLEA and, if approved, we hope it will provide a new treatment option for patients with macular edema following BRVO.”

Bayer and Regeneron are collaborating on the global development of EYLEA.  The current sBLA submission is based on positive results from the double-masked, randomized, active-controlled Phase III trial VIBRANT. The study involved 183 patients with macular edema following branch retinal vein occlusion who received either intravitreal EYLEA 2 milligrams (mg) every four weeks or laser treatment for 24 weeks. VIBRANT’s primary objective is to compare improvement in best-corrected visual acuity against laser treatments at week 24. The study is currently ongoing through week 52.

Branch retinal vein occlusion is the second most common retinal vascular disorder and a significant cause of visual impairment. Retinal vein occlusion occurs in two main types, CRVO and BRVO. BRVO is the more common of the two wherein blockage occurs in the blood vessels branching from the main vein responsible for the drainage of the retina. BRVO results in the release of vascular endothelial growth factor (VEGF) and ensuant retinal edema.

EYLEA, also known as VEGF Trap-Eye in scientific literature, is a recombinant fusion protein comprised of portions of human VEGF receptors 1 and 2 extracellular fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. The treatment acts as a soluble decoy receptor which binds VEGF-A and placental growth factor to inhibit binding and activation of cognate VEGF receptors.

The aim for a standard sBLA review is ten months from submission. Regeneron looks to a target action date of October 23, 2014 for its EYLEA supplemental biologics license application.