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AstraZeneca (NASDAQ:AZN) has received FDA approval for its drug Voydeya, also known as danicopan, as an add-on therapy to Ultomiris or Soliris in the treatment of extravascular hemolysis in adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria, or PNH.
AstraZeneca said Voydeya was developed as an add-on medication to its PNH drugs Ultomiris or Soliris for the approximately 10% to 20% of patients who experience clinically significant extravascular hemolysis while treated with a C5 inhibitor.
Voydeya was approved by Japanese regulators in January and has been recommended for approval in the EU, AstraZeneca said.