Agios Pharmaceuticals, Inc. (AGIO), a commercial-stage biopharmaceutical firm, and its partner Avanzanite Bioscience B.V., announced that the European Commission EC has granted marketing authorisation for Agios' lead asset, PYRUKYND or Mitapivat, an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia.
The approval of PYRUKYND reflects a second indication in the EU, following its 2022 approval for adults with Pyruvate Kinase Deficiency.
The approval includes an orphan medicinal product designation. The EC's decision was supported by the positive opinion issued by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and is based on results from ENERGIZE and ENERGIZE-T Phase 3 trials.
Thalassaemia is a rare, inherited blood disease that affects the production of haemoglobin, which carries oxygen throughout the body. The disease is categorised into two main types: alpha-thalassaemia and beta-thalassaemia, depending on which globin chain of the haemoglobin is affected.
ENERGIZE and ENERGIZE-T Phase 3 trials are global, randomised, double-blind, placebo-controlled studies that evaluated the efficacy and safety of Mitapivat in adults with alpha- or beta-thalassaemia.
Under its existing exclusive agreement with Agios made in June 2025, Avanzanite Bioscience will commercialise and distribute Pyrukynd across the European Economic Area, the United Kingdom and Switzerland.
"Our role now is to collaborate with local authorities, drive a successful launch, and enable broad access to PYRUKYND," said Adam Plich, CEO and Co-Founder of Avanzanite Bioscience.
AGIO has traded between $22.24 and $46.00 over the last year. AGIO closed Friday's trade at $28.14, down 2.26%.
AGIO is down 1.92% at $27.60 in the overnight market.
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