08.14.18

Regeneron Faces Delay to FDA Approval of 12-Week Dosing Schedule for Eylea in Wet AMD

Source: FirstWord

Regeneron announced that the FDA issued a complete response letter regarding a filing seeking approval of a 12-week dosing schedule for »Eylea (aflibercept) in patients with wet age-related macular degeneration (AMD). The company noted that the move was taken “due to ongoing labeling discussions” with the agency, with a final decision from the regulator expected within 2 months.

Eylea, which is marketed by Bayer outside of the US, is currently approved in wet AMD for every 4- or 8-week dosing intervals after three initial monthly doses. The supplemental marketing application is based on second-year data from the VIEW studies during which patients were treated with a modified 12-week dosing schedule of the VEGF inhibitor.

The delay comes as Novartis looks to gain FDA approval of brolucizumab, also known as RTH258, in patients with neovascular AMD. Last year, the Swiss drugmaker reported that brolucizumab demonstrated noninferiority to Eylea in two late-stage studies, with the former being dosed on a 12-week interval following a three-month loading phase. At the time, Novartis indicated that regulatory filings for the therapy are planned for 2018.

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