Voydeya (danicopan) granted first-ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy
Approval of first-in-class, oral, Factor D inhibitor based on ALPHA Phase III trial in a subset of patients with PNH. Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an insufficient response to such C5 inhibitors.[1] Voydeya is a first-in-class, oral, Factor D inhibitor developed as add-on to proven standard-of-care Ultomiris or Soliris to address the needs of the subset of patients (approximately 10-20%) with PNH who experience