FDA approves Pyrukynd for anemia in adults with rare inherited disorder

The US Food and Drug Administration on Thursday, under its accelerated review process, approved Agios Pharmaceuticals’ (Nasdaq: AGIO) Pyrukynd (mitapivat) tablets to treat hemolytic anemia (a disorder in which red blood cells are destroyed faster than they can be made) in adults with pyruvate kinase (PK) deficiency.

The drug is expected to be available in the USA in around two weeks post approval, noted Adios, whose shares were up 6.8% at $31.46 in after-hours trading on Thursday.

Because of drug interactions, patients should either avoid using Pyrukynd with certain other medications or adjust the Pyrukynd dose, the FDA noted. Abruptly stopping Pyrukynd could worsen premature red blood cell destruction. Patients should avoid suddenly stopping or pausing Pyrukynd and follow their health care provider’s instructions for discontinuing treatment, the agency warned.