Ultomiris approved in Japan for the treatment of adults with generalised myasthenia gravis. Alexion/AstraZeneca
-Ultomiris (ravulizumab) from Alexion/ AstraZeneca has been approved in Japan for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis
Japan’s Pharmaceuticals and Medical Devices Agency also indicated that Ultomiris can be considered for patients who cannot receive high-dose IVIg or plasmaphaeresis due to complications, adverse reactions or other limiting factors.
The approval of the first and only long-acting C5 complement inhibitor by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the CHAMPION-MG Phase III trial, which showed Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities.
Additionally, in prolonged follow-up results from the open-label extension, clinical benefit of Ultomiris was observed through 60 weeks.
gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. The diagnosed prevalence of gMG in Japan is estimated at approximately 22,000.
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