- Agios Pharmaceuticals Inc (NASDAQ:AGIO) has submitted an FDA marketing application seeking approval for mitapivat to treat adults with pyruvate kinase (PK) deficiency.
- The company says, if approved, mitapivat could be the first potentially disease-modifying therapy for PK deficiency.
- The submission is based on two studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively.
- A complete analysis of these data was recently presented at the European Hematology Association Virtual Congress.
- An extension study for adults with PK deficiency previously enrolled in ACTIVATE or ACTIVATE-T is ongoing and designed to evaluate the long-term safety, tolerability, and efficacy of treatment with mitapivat.
- The company remains on track to submit a marketing application in the EU in mid-2021 for mitapivat in adults with PK deficiency.
- Price Action: AGIO shares are up 0.86% at $61 on the last check Monday.
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