Mitapivat
Mitapivat Receives FDA Approval For Haemolytic Anaemia From Pyruvate Kinase Deficiency
Clinical News
February 18, 2022
Mitapivat Receives FDA Approval For Haemolytic Anaemia From Pyruvate Kinase Deficiency
The US Food and Drug Administration (FDA) has announced the approval of Mitapivat (PYRUKYND®) tablets as treatment for haemolytic anemia in adults with pyruvate kinase (PK) deficiency. The oral PK…
Mitapivat Granted Priority Review By The FDA For Pyruvate Kinase (PK) Deficiency
Clinical News
August 19, 2021
Mitapivat Granted Priority Review By The FDA For Pyruvate Kinase (PK) Deficiency
The U.S. Food and Drug Administration (FDA) has accepted Agios’ New Drug Application (NDA) for Mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency. The NDA was granted…
Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
Clinical News
June 22, 2021
Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
Agios Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) for Mitapivat to the U.S. Food and Drug Administration (FDA) for the treatment of adults with pyruvate…
FDA Grants Orphan Drug Designation to Mitapivat for Treatment of Thalassaemia
Clinical News
June 11, 2020
FDA Grants Orphan Drug Designation to Mitapivat for Treatment of Thalassaemia
Agios Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s first-in-class pyruvate kinase-R (PKR) activator Mitapivat for the treatment of…