Shots:
- The CHMP has recommended Voydeya as an add-on therapy to SoC for treating PNH adult patients with residual haemolytic anaemia
- The recommendation was based on the P-III (ALPHA) study investigating the safety & efficacy of Voydeya as an add-on therapy to Ultomiris or Soliris (SoC) for treating PNH patients with extravascular haemolysis (EVH)
- The study achieved its 1EP of change in hemoglobin from baseline to wk. 12 along with the 2EPs incl. transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) score. The drug was well tolerated without any safety concerns. Data from the 12-wk. primary analysis was published in The Lancet Haematology
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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