Regeneron data update on Eylea overshadowed by CRL

26 October 2018

Regeneron Pharmaceuticals (Nasdaq: REGN) announced positive Phase III trial news on its ophthalmology drug Eylea (aflibercept) in diabetic eye disease on Thursday.

But investors were likely more concerned at news that the US biotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the Chemistry, Manufacturing and Controls Prior-Approval Supplement (PAS) for the Eylea pre-filled syringe.

The CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in around 30 patients.

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