CHMP Gives Nod To Regeneron's EYLEA (aflibercept) Injection
By Lori Clapper
The European Committee for Medicinal Products for Human Use (CHMP) approved Regeneron’s EYLEA Injection for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014, the company announced last Friday.
Regeneron reports that “The European Union (EU) submission is based on positive data from the Phase 3 VIVID-DME and VISTA-DME studies.” In fact, both studies saw significant improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.
While one-year data from the VIVID-DME and VISTA-DME trials and two-year data from the VISTA-DME trial have already been presented at medical congresses, each of the trials should continue as planned up to 148 weeks.
"Diabetes is a growing health concern worldwide and this milestone brings us one step closer to being able to offer patients and physicians in the European Union a new therapeutic option for the treatment of diabetic macular edema," George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added.
EYLEA was approved in the U.S. for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. In addition, EYLEA is in use in the EU and other countries for use in wet AMD and Macular Edema following CRVO. The company said that regulatory submissions have also been made in Japan, Asia Pacific, Latin America, and the U.S., for the treatment of Diabetic Macular Edema as well as macular edema following Branch Retinal Vein Occlusion (BRVO).
As part of a strategic collaboration, Bayer HealthCare is licensed for the exclusive marketing rights outside the United States, while Regeneron maintains exclusive rights to EYLEA in the United States.