Posted by Michael Wonder on 29 Jun 2021
Agios submits marketing authorisation application to European Medicines Agency for mitapivat for treatment of adults with pyruvate kinase deficiency
28 June 2021 - Agios Pharmaceuticals today announced that it has submitted a marketing authorisation application for mitapivat to the EMA for the treatment of adults with pyruvate kinase deficiency in the European Union.
This submission follows the company’s recent new drug application submission of mitapivat to the U.S. FDA for treatment of adults with pyruvate kinase deficiency in the U.S.
Like the new drug application, the marketing authorisation application submission is based on results from two pivotal studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with pyruvate kinase deficiency, respectively.
