AstraZeneca PLC said Monday that ultomiris has been recommended for approval in the EU for the treatment of adults with generalized myasthenia gravis.
The pharmaceutical giant said that the committee for medicinal products for human use of the European Medicines Agency based its decision on results from the Champion-MG Phase 3 trial.
Ultomiris has been recommended as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.
Generalized myasthenia gravis is a debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness.
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