Agios Says US FDA Grants Priority Review for Mitapivat to Treat Sickle Cell Disease
Agios Pharmaceuticals (AGIO) said Tuesday that the US Food and Drug Administration granted Priority Review to its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, for the treatment of sickle cell disease. The company said the Prescription Drug User Fee Act target action date is Nov. 1. The priority review designation is based on data from the global, randomized, double-blind, placebo-controlled mid-stage and late-stage trials in patients aged 16 years and older with sickle cell disease, the company said. If approved, mitapivat would become the first oral pyruvate kinase activator for patients with sickle cell disease. Shares of Agios were up almost 3% in recent Tuesday premarket activity.
Agios Pharmaceuticals (AGIO) said Tuesday that the US Food and Drug Administration granted Priority Review to its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, for the treatment of sickle cell disease.
The company said the Prescription Drug User Fee Act target action date is Nov.
1.
The priority review designation is based on data from the global, randomized, double-blind, placebo-controlled mid-stage and late-stage trials in patients aged 16 years and older with sickle cell disease, the company said.
If approved, mitapivat would become the first oral pyruvate kinase activator for patients with sickle cell disease.
Shares of Agios were up almost 3% in recent Tuesday premarket activity.