AstraZeneca's Ultomiris gets approval in Japan for expanded use in rare nervous system disorder
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AstraZeneca's (NASDAQ:AZN) Ultomiris received expanded approval in Japan to prevent relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.
The British pharma giant said Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for this use.
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was backed by data from a phase 3 trial called CHAMPION-NMOSD.
"With todayâs approval, we continue to deliver on our commitment to the NMOSD community, offering patients an innovative long-acting treatment option that has the potential to eliminate relapses with convenient dosing every eight weeks," said Marc Dunoyer, CEO of Alexion, the rare disease unit of AstraZeneca.
Earlier this month, Ultomiris received expanded approval for this indication in the EU as well.
NMOSD is a central nervous system disorder which causes inflammation in nerves of the eye and spinal cord. The disorder occurs when the immune system reacts against its own cells.
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