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Agios discontinues AG-519 drug development after FDA feedback

Agios Pharmaceuticals Inc. withdrew its investigational new drug application for its pyruvate kinase-R activator, AG-519, after a verbal notification of a clinical hold from the U.S. FDA.

The company has also discontinued development of the drug.

Agios said these decisions do not affect the ongoing global phase 2 study for AG-348, an activator of both wild-type and mutated pyruvate kinase-R enzymes, as a potential disease-modifying treatment for pyruvate kinase deficiency.

Pyruvate kinase deficiency is a rare, inherited disease that presents as hemolytic anemia, which is the accelerated destruction of red blood cells.