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FDA issues complete response letter on Eylea 12-week dosing

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The FDA has issued a complete response letter regarding Regeneron’s supplemental biologics license application for 12-week dosing of Eylea, the company announced in a press release.

The letter was issued because of “ongoing labeling discussions,” the release said.

The application was based on second-year data from the VIEW studies, in which patients with wet age-related macular degeneration received Eylea (aflibercept) injections at least every 12 weeks, with additional doses as needed, the release said.

The current recommended dose of Eylea for wet AMD is a 2-mg injection every 8 weeks after three initial monthly injections.

Final FDA action is expected within 2 months.