Agios' Rare Anemia Drug Application Under FDA Priority Review

by Vandana Singh, Benzinga Editor

August 18, 2021 7:03 AM | 1 min read | Make a Comment

The FDA has accepted Agios Pharmaceuticals Inc's AGIO marketing application seeking approval for mitapivat for pyruvate kinase (PK) deficiency.
Under Priority Review designation, the agency's action date is assigned as of February 17, 2022.
Related: Agios Pharma Files US Application For Mitapivat In PK Deficiency.
Mitapivat application is under review with the European Medical Agency for the same indication.
Pyruvate kinase (PK) deficiency is a rare, inherited disease that presents chronic hemolytic anemia, the accelerated destruction of red blood cells.
Related content: Benzinga's Full FDA Calendar.
Price Action: AGIO shares closed 2.38% higher at $44.65 on Tuesday.