US FDA approves Agios’ Aqvesme (mitapivat) for the treatment of anaemia in adults with alfa or beta-thalassaemia

Agios Pharmaceuticals

23 December 2025 - Aqvesme expected to be available in late January 2026, following Aqvesme REMS program implementation.

Agios Pharmaceuticals today announced that the US FDA has approved Aqvesme (mitapivat), an oral pyruvate kinase activator, for the treatment of anaemia in adults with alpha- or beta-thalassaemia.

Read Agios Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration