VEGF Trap-Eye Delayed By FDA
The FDA delayed its approval of the VEGF Trap-Eye drug Eylea, despite its advisory panel’s recommendations, and extended the target date for completion of its review of the medicine to November 18th. There were questions on the company’s application regarding chemistry, manufacturing, controls and sales.
The drug, Eylea, manufactured by Regeneron Pharmaceuticals, would compete with Roche’s Lucentis. It only has to be injected every eight weeks, half as often as Lucentis.
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