AstraZeneca says Voydeya recommended for approval in the EU by CHMP

Voydeya has been recommended for marketing authorisation in the European Union as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria, or PNH, who have residual haemolytic anaemia, AstraZeneca announced. The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency based its positive opinion on results from the pivotal ALPHA Phase III trial. Results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology. Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris or Soliris to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis, or EVH, while treated with a C5 inhibitor.