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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.

Obtaining approval of danicopan could be a key factor in maintaining dominance in the complement inhibitor space – AstraZeneca became the sector leader with its $39bn buyout in December 2020 of Alexion Pharmaceuticals Inc., manufacturer of PNH therapies Ultomiris (ravulizumab) and Soliris (eculizumab). (Also see "AZ's Alexion Acquisition Looks Astute Bit Of Business" - Scrip, 13 December, 2020

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