19th Jan 2024 09:28
(Alliance News) - AstraZeneca PLC on Friday said its inhibitor Voydeya, also known as danicopan, received approval in Japan for adults with paroxysmal nocturnal haemoglobinuria, or PNH.
The Cambridge-based pharmaceutical company said the approval by the Japanese Ministry of Health, Labour & Welfare is for adults with PNH to be used in combination with C5 inhibitor therapy.
The approval is based on positive results from a phase three trial.
PNH is a rare and severe blood disorder characterised by the destruction of red blood cells within blood vessels, known as intravascular haemolysis. It can result in blood clots, organ damage and potentially premature death.
Marc Dunoyer, chief executive officer of AstraZeneca's rare disease-focused unit Alexion, said: "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 extravascular haemolysis 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."
AstraZeneca shares were 1.2% higher at 10,554.00 pence each on Friday morning in London.
By Tom Budszus, Alliance News slot editor
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