16 September 2022 - Agios expects a decision on the marketing authorisation application by the European Commission within 67 days of the adoption of the positive CHMP opinion.
Agios Pharmaceuticals today announced that the CHMP of the EMA adopted a positive opinion on 15 September 2022, recommending the granting of a marketing authorisation for Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency in adult patients.