Agios Pharmaceuticals Plans Accelerated Approval Filing for Mitapivat in Sickle Cell Disease

MT Newswires Live03-31

Agios Pharmaceuticals (AGIO) said Tuesday that it plans to pursue US accelerated approval for mitapivat in sickle cell disease following a pre-supplemental New Drug Application meeting with the US Food and Drug Administration.

The commercial-stage company said that based on the discussions, the FDA recommended submission of a confirmatory clinical trial proposal, which Agios has already provided. The company said it expects to file an sNDA in the coming months.

Results from a late-stage trial showed mitapivat has met the primary endpoint of hemoglobin response, demonstrating a statistically significant improvement versus placebo, Agios said. The drug has also reduced pain crises, though that endpoint did not reach statistical significance, the company said.

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