Agios' Rare Anemia Drug Application Under FDA Priority Review

Agios' Rare Anemia Drug Application Under FDA Priority Review
  • 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. 

Posted In: AnemiaBriefsFDA Priority ReviewBiotechNewsHealth CareFDAGeneral