Managed Healthcare Executive April 6, 2024
The FDA has approved several new therapies this week, including Voydeya as an add-on therapy for blood disorder PNH; Zevtera for serious bacterial infections; Fanapt for bipolar 1; and the CAR-T therapy Abecma for earlier treatment in multiple myeloma. The agency has also accepted a supplemental BLA for Bimzelx in hidradenitis suppurativa and set a review date for datopotamab deruxtecan in breast cancer.
FDA Approves Voydeya as Add-on Therapy in Rare Blood Disorder
The FDA has approved Alexion/AstraZeneca’s Voydeya (danicopan) as add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH). It is indicated for those patients with extravascular hemolysis (EVH) where red blood cells are destroyed outside of the blood vessel despite...
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