AstraZeneca has announced FDA approval of Ultomiris, a long-acting C5 complement inhibitor for the treatment of adults with generalized myasthenia gravis.
According to a company press release, Ultomiris (ravulizumab-cwvz) was approved for adult patients who are anti-acetylcholine receptor antibody-positive, which represents 80% of people with the disease. It is estimated that generalized myasthenia gravis affects approximately 90,000 people in the U.S.
Approval of the drug was based on positive results from the CHAMPION-MG phase 3 trial, in which ravulizumab-cwvz was more effective than placebo