Regeneron sees rejection one day, US FDA approval the next

By Flora Southey contact

- Last updated on GMT

(Image: Getty/kwasny221)
(Image: Getty/kwasny221)

Related tags: Regeneron, Eye, Fda

The US FDA has approved Regeneron’s latest indication for eye drug Eylea, just four days after rejecting the sBLA in a complete response letter.

Regeneron Pharmaceuticals announced approval of its supplemental biologics license application (sBLA) for Eylea (aflibercept) injection, with a 12-week dosing schedule, earlier today. The drug is already approved for four- or eight-week dosing intervals, after three initial monthly doses.

"Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration,"​ said Regeneron president, George Yancopoulos, in a statement​.

Eylea injection is a vascular endothelial growth factor inhibitor, designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye.

The approval comes just days after the firm received a complete response letter​ (CRL) from the US Food and Drug Administration (FDA), which rejected the candidate due to “ongoing labelling discussions”, ​said Regeneron. On Monday, the biotech said it expected a final regulatory decision within two months.

 “Our two-month estimate was based on the expectation that our resubmission would be ‘Class 1​’, which ‘starts a new 2-month review cycle beginning on the date FDA receives the resubmission’,​ a Regeneron spokesperson told us.

“We were pleased to have been able to complete our label discussions with the FDA quickly and receive their approval on this submission,”​ he added.

Related topics: Markets & Regulations

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