Posted by Michael Wonder on 25 Oct 2018
FDA declines to approve pre-filled syringe version of Regeneron's Eylea
25 October 2018 - Regeneron Pharmaceuticals said on Thursday the U.S. FDA declined to approve a pre-filled syringe version of its blockbuster eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes.
The drug maker said the rejection does not affect its earlier expectation of launching the product in 2019. It plans to resubmit its application early next year.
Regeneron told Reuters the regulator has also asked for the completion of a small study, involving about 30 patients, to demonstrate doctors are able to administer the product.
