FDA to rule on fusion protein

Tarrytown, NY-Look for an FDA decision about Regeneron Pharmaceuticals’ biologics license application (BLA) for a fusion protein (VEGF Trap-Eye) for the treatment of the neovascular form of age-related macular degeneration (AMD) by Aug. 20 now that the agency has granted the company’s request for priority review.

“We are very pleased that the FDA has chosen to grant priority review to [the fusion protein],” said Leonard S. Schleifer, MD, PhD, president and chief executive officer of Regeneron. “We look forward to working closely with the FDA to achieve our goal of bringing a new treatment option that offers a major advance to patients with AMD.”

Regeneron and Bayer HealthCare are collaborating on the development of the fusion protein for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularization, and other eye diseases and disorders.

Bayer HealthCare plans to submit a regulatory application outside of the United States in the first half of this year. If approved by authorities, Bayer HealthCare will market the fusion protein outside the United States, where the companies will share equally in profits from any future sales. Regeneron maintains exclusive rights to the fusion protein in the United States.