German pharmaceutical giant Bayer (ETR: BAYN) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the label extension of Eylea 8 mg (aflibercept 8 mg, 114.3 mg/mL injection). This extension would allow treatment intervals of up to 6 months for neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). If approved by the European Commission in the coming weeks, Eylea 8 mg will become the only anti-VEGF therapy in the EU with a 6-month dosing interval for both conditions.
Current Indications
Aflibercept, a VEGFR-Fc fusion protein co-developed by Bayer and Regeneron, was first approved in the U.S. in November 2011 under the brand name Eylea. Current indications include nAMD, retinal vein occlusion (RVO), diabetic retinopathy, and other ocular disorders.-Fineline Info & Tech
