26th May 2023 14:34
(Alliance News) - AstraZeneca PLC on Friday announced that its antibody complement inhibitor drug Ultomiris received another approval in Japan.
The Cambridge-based pharmaceutical company said Ultomiris was approved by Japan's Ministry of Health, Labour & Welfare for the prevention of relapses in patients with neuromyelitis optica spectrum disorder, or NMOSD.
NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system, including the spine and optic nerves, the company explained.
The approval was based on positive results from the CHAMPION-NMOSD phase 3 trial, which showed a relapse risk reduction of 98.6% for patients with a median treatment duration of 73 weeks.
Ichiro Nakashima, Professor at the Division of Neurology, Tohoku Medical & Pharmaceutical University, Sendai, Japan said: "As a single NMOSD relapse can result in long-term and life-altering disability, relapse prevention is the primary treatment goal in this disease and essential to help patients maintain quality of life. With no relapses observed in the pivotal CHAMPION-NMOSD trial, the approval of this long-acting C5 complement inhibitor in Japan is a significant advance for patients with anti-aquaporin-4 antibody-positive NMOSD, offering dosing every eight weeks and the potential to live relapse-free."
In August last year, the drug was approved in Japan for adults with generalised myasthenia gravis - a rare, debilitating, chronic condition that causes muscle weakness.
AstraZeneca shares were 0.9% higher at 11,748.00 pence each on Friday afternoon in London.
By Tom Budszus, Alliance News reporter
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