Voydeya (danicopan) is approved as an add-on to the standard-of-care — AstraZeneca's C5 inhibitorsC5 inhibitors, Ultomiris (ravulizumab) or Soliris (eculizumab) — to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular hemolysis (EVH) while treated with a C5inhibitor. For some patients, EVH, which is the destruction of red blood cells outside of the blood vessels, results in continued symptoms of anemia and may require blood transfusions.
Voydeya will go up against Novartis' Factor B inhibitor, branded Fabhalta, which was approved as the first oral monotherapy for the treatment of adults with PNH back in December. According to Novartis, Fabhalta addresses the unmet needs of patients being treated with AstraZeneca's Ultomiris or Soliris, including EVH. Fabhalta was tested against Ultomiris or Soliris in the open-label APPLY-PNH trial, where the drug proved superiority.
But, AstraZeneca's trial results for Voydeya suggest that a dual complement pathway inhibition at Factor D and C5 may be an optimal treatment approach for EVH patients.