Regeneron has received a CRL tied to the manufacturing of a prefilled syringe for use with Eylea. (Regeneron)
Regeneron’s top-selling blockbuster Eylea has shown good results for a new and potentially lucrative indication, hitting its one-year endpoints in a phase 3 trial for treatment of diabetic eye disease. Its prefilled syringe, however, did not.
The FDA has issued a complete response letter (CRL) tied to the manufacturing of the pre-filled syringe and asked for more info about that and the supply processes. In addition, it wants Regeneron to complete a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients as part of the pre-approval process.