Agios Pharmaceuticals

New Capabilities

Awaiting an FDA decision on mitapivat for sickle cell disease, now due February 1, 2027

The FDA pushed its decision on mitapivat for sickle cell disease from November 1, 2026 to February 1, 2027. On October 9 the agency asked whether the drug needs a risk plan, known as a REMS, to manage safety. Agios sent nine months of extra safety data on October 19; the FDA called that a major amendment on October 28 and added three months to the review.

Updated Nov 2