- AstraZeneca Plc AZN said his danicopan add-on drug for blood clotting met a primary endpoint in the phase 3 ALPHA study in patients with paroxysmal nocturnal hemoglobinuria (PNH) who are experiencing clinically significant extravascular hemolysis (EVH).
- A pre-specified interim analysis of the Phase 3 study evaluating danicopan (ALXN2040) as add-on therapy to C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) showed positive results.
- Related: AstraZeneca settles Ultomiris-related patent dispute with Chugai.
- Danicopan plus Ultomiris or Soliris was shown to be superior to placebo plus Ultomiris or Soliris, with statistically significant and clinically meaningful improvements from baseline in hemoglobin, transfusion avoidance, and fatigue scores.
- PNH is a rare blood disorder characterized by the destruction of red and white blood cells and activation of platelets, causing blood clots and leading to organ damage and possible premature death.
- Danicopan was generally well tolerated and no clinically meaningful differences in safety outcomes were observed between the danicopan plus C5 inhibitor group and the control group.
- Price promotion: AZN shares are up 2.08% to $59.35 during the premarket session last Check Friday.
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