FDA accepts NDA for Takeda's Oveporexton and grants priority review as a potential narcolepsy therapy

The U.S. Food and Drug Administration has accepted Takeda's New Drug Application for Oveporexton (TAK-861) and granted it priority review, the company announced in a press release.

Takeda announced that the U.S. Food and Drug Administration has accepted its New Drug Application for Oveporexton (TAK-861) and granted the filing priority review. The submission is for treatment of narcolepsy type 1 and is described by the company as a potential first‑in‑class therapy. The announcement appeared in a Takeda press release that also includes standard forward‑looking statements and disclaimers. The press release did not provide a timeline for the FDA's review or a decision date. Key points: - The U.S. Food and Drug Administration accepted Takeda's New Drug Application for Oveporexton (TAK-861). - The FDA granted priority review for the application. - The application is for treatment of narcolepsy type 1 and is described as a potential first‑in‑class therapy. - The announcement was made in a Takeda press release that includes forward‑looking statements and risk disclaimers. Summary: The FDA's acceptance and priority review initiate the regulatory evaluation of Oveporexton for narcolepsy type 1. The press release did not state a review timeline or expected decision date. Undetermined at this time.