Regeneron’s Eylea wins FDA approval for wet age-related macular degeneration

pharmafile | August 20, 2018 | News story | Sales and Marketing Bayer, Eylea, FDA, Regeneron, US, pharma 

Regeneron is celebrating the approval in the US of its vascular endothelial growth factor (VEGF) inhibitor Eylea (aflibercept) for the treatment of wet age-related macular degeneration (AMD).

The decision was based on second-year Phase 3 data from two trials, demonstrating the efficacy of Eylea in treating wet AMD with a 12-week dosing schedule.

Earlier the same week, the US regulator had voiced its dissatisfaction in the level of data supplied in support of the drug in a complete response letter, but had changed its mind by the Friday, with no reason given for the U-turn.

“We are pleased that the FDA has approved an updated label for EYLEA,” said Dr George D Yancopoulos, President and Chief Scientific Officer of Regeneron. “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.”

Last month, Eylea also secured approval in Europe, under Regeneron’s partner Bayer, who is handling commercialisation in the region. Overall, the drug is now approved for the treatment of wet AMD on four- and eight-week dosing intervals after three initial monthly doses.

Matt Fellows

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