FDA extends aflibercept review

Tarrytown, NY-The FDA has extended by 3 months its target date to complete a priority review of the biologics license application (BLA) of aflibercept injection for intravitreal use (Eylea, also known as VEGF Trap-Eye, Regeneron Pharmaceuticals) for the treatment of neovascular age-related macular degeneration (AMD) to Nov. 18.

The agency classified recent responses to questions regarding the chemistry, manufacturing, and controls section of the BLA as a major amendment to the application, according to the company. The new action date will give the agency additional time to review the submitted information.

Regeneron maintains exclusive rights to aflibercept injection in the United States, but the company is collaborating with Bayer HealthCare on the global development of the fusion protein for the treatment of neovascular AMD, central retinal vein occlusion, diabetic macular edema, and other eye diseases and disorders.

Bayer HealthCare will market aflibercept injection outside the United States, where the companies will share equally in the profits from any future sales of the fusion protein. In June, Bayer submitted an application to market the product for wet AMD in Europe.