AstraZeneca’s Voydeya approved in Japan for PNH treatment
Betsy Goodfellow | January 19, 2024 | News story | Medical Communications | AstraZeneca, Haematology, PNH, Voydeya
AstraZeneca has announced that Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), in combination for C5 inhibitor therapy when patients have had an insufficient response to C5 inhibitors alone.
The drug is a first-in-class, oral, Factor D inhibitor, which has been developed as an add-on therapy to standard-of-care drugs Ultomiris or Soliris, in order to address the needs of the approximate 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while receiving treatment with a C5 inhibitor.
The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) followed results from the phase 3 ALPHA trial, which were published in The Lancet Haematology. This trial assessed the safety and efficacy of Voydeya as an add-on to Ultomiris or Soliris in patients with PNH who experienced clinically significant EVH. The drug met its primary endpoint, and results showed that it was generally well tolerated with no new safety concerns arising. The most common adverse events were headache, nausea, arthralgia and diarrhoea.
Marc Dunoyer, chief executive officer at Alexion, commented: “More than 20 years of PNH research has cemented the role of C5 inhibition in effectively treating this rare disease, and we continue to innovate for this community. Voydeya, as add-on to standard-of-care, is a testament to our determination to address the needs of those impacted by clinically significant EVH without disruption to proven therapy. We look forward to bringing this important advancement to the subset of PNH patients in Japan who are living with this condition.”
Betsy Goodfellow
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