Aflibercept gains new approval, recommendation


Aflibercept (Eylea, Regeneron) has gained FDA approval for treatment of macular edema following CRVO and recommendation for approval by the CHMP for treatment of neovascular AMD.

Tarrytown, NY-Regeneron Pharmaceuticals Inc. announces that aflibercept (Eylea) has gained FDA approval for treatment of macular edema following central retinal vein occlusion (CRVO). In addition, the drug has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for treatment of neovascular (wet) age-related macular degeneration.

The approval of aflibercept, an inhibitor of vascular endothelial growth factor (VEGF), for macular edema following CRVO was based on data from the phase III COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of best corrected visual acuity at 24 weeks compared with baseline as measured by ETDRS.

Bayer HealthCare and Regeneron are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to aflibercept in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales, except for Japan where Regeneron will receive a royalty on net sales.

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