The FDA approved AstraZeneca's Voydeya (danicopan) as an add-on therapy for adults with PNH and EVH based on positive ALPHA trial results.
The US FDA has approved AstraZeneca's Voydeya (danicopan) as an add-on therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH) experiencing extravascular hemolysis (EVH). The approval follows positive results from the ALPHA phase 3 clinical trial, which demonstrated that patients treated with danicopan in addition to their C5 inhibitor therapy showed better changes in hemoglobin from baseline to week 12 compared to those who received placebo. Voydeya is the first-in-class Factor D inhibitor and is also approved in Japan for use in combination with a C5 inhibitor therapy for certain adults with PNH.
April 01, 2024
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