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AstraZeneca Hopes Danicopan Interim Data Will Prove Sufficient For NDA Filing

 
• By Joseph Haas

Danicopan seen as potential add-on therapy for paroxysmal nocturnal hemoglobinuria patients getting suboptimal results from Soliris or Ultomiris therapy. AstraZeneca will investigate filing for approval on 12-week data.

Hemolysis
AstraZeneca thinks danicopan can provided added benefit for some PNH patients • Source: Shutterstock

AstraZeneca PLC hopes interim data from a Phase III trial of danicopan will be sufficient to file the novel factor D inhibitor for approval to treat extravascular hemolysis (EVH) in patients who take Ultomiris or Soliris for paroxysmal nocturnal hemoglobinuria (PNH). The biopharma reported on 16 September that 12-week data from the ALPHA trial shows that danicopan met the primary endpoint of change in hemoglobin levels from baseline as well as key secondary endpoints.

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