Agios Pharmaceuticals, Inc. (AGIO) announced Tuesday its decision to advance U.S. accelerated approval of mitapivat for the treatment of sickle cell disease, following completion of its pre-supplemental New Drug Application meeting with the U.S. Food and Drug Administration.
Based on the meeting, the FDA recommended submission of a proposal for a confirmatory clinical trial to support U.S. accelerated approval of mitapivat.
As part of the decision, the company has already submitted its proposal for the required confirmatory clinical trial to the FDA for review, which comprises a primary endpoint that is different from those in the RISE UP clinical program and is informed by both analyses of RISE UP data and discussions with the FDA.
Moreover, Agios plans to submit a mitapivat sNDA for sickle cell disease in the coming months. Also, it is working with the FDA to achieve alignment on the confirmatory clinical trial required for submission.
In the pre-market hours, AGIO is trading at $33.98, up 14.76 percent on the Nasdaq.
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