Bayer seeks EU market authorization

Berlin-Bayer HealthCare has submitted an application for marketing authorization in Europe for a fusion protein (VEGF Trap-Eye) for the treatment of neovascular age-related macular degeneration (AMD).

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

“The submission of [the fusion protein] for European Union marketing authorization represents a significant milestone in our goal to bring this potentially important new therapy to patients with wet AMD across the globe,” said Leonard S. Schleifer, MD, PhD, president and chief executive officer of Regeneron.

The submission is based on the positive results from two phase III clinical trials: the  VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 study and the VIEW 2 study. In these trials, all regimens of the fusion protein (including 2 mg dosed every 2 months following three loading doses) successfully met the primary endpoint of non-inferiority, compared with the current standard of care, ranibizumab (Lucentis, marketed by Genentech in the United States and Novartis in the rest of the world) 0.5 mg dosed every month, according to the companies.

The primary endpoint analysis was statistical non-inferiority in the proportion of patients in whom vision was maintained or improved over 52 weeks compared with ranibizumab at the dose that is currently known to provide the best possible efficacy. A generally favorable safety profile was observed for both the fusion protein and ranibizumab, according to Regeneron and Bayer HealthCare, and the ocular adverse events were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms, the companies stated.

Regeneron submitted a biologics license application for marketing approval of the fusion protein for the treatment of wet AMD in the United States in February and received a priority review designation.

If the application is approved, Bayer HealthCare will market the fusion protein outside the United States, where the companies will share profits from any future sales of the fusion protein equally. Regeneron maintains exclusive rights to the fusion protein in the United States.