Drug news

Eylea (Bayer/Regeneron) filed at FDA and EU for DME

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Last updated:9th Nov 2013

Published:9th Nov 2013

Source: Pharmawand

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced on 7 November 2013 that Bayer HealthCare has submitted an application for marketing authorization in the European Union (EU) for Eylea (aflibercept) Injection for the treatment of patients with Diabetic Macular Edema (DME). Regeneron has submitted a supplemental BLA for Eylea in this indication to the FDA.

The submission of Eylea for DME is based on data from the positive Phase III VISTA-DME and VIVID-DME studies. One-year data from both trials have been presented at medical conferences. The VISTA-DME and VIVID-DME trials are planned to continue up to 148 weeks.

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