AstraZeneca’s Ultomiris Approved in China for Generalized Myasthenia Gravis

AstraZeneca's Ultomiris Approved in China for Generalized Myasthenia Gravis

UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has announced that the National Medical Products Administration (NMPA) in China has granted marketing approval for its long-acting C5 complement inhibitor Ultomiris® (ravulizumab). This approval allows the drug to be used in combination with conventional therapy for adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG).

Clinical Trial Success
The approval is based on positive results from the Phase III CHAMPION-MG trial. The study demonstrated that ravulizumab significantly improved Myasthenia Gravis-Activities of Daily Living (MG-ADL) scores at the primary endpoint of Week 26 compared to placebo, with sustained efficacy through 164 weeks. The drug showed a 71.1% reduction in the annualized risk of disease progression versus placebo. Its safety profile was comparable to placebo, with common adverse reactions including nausea, headache, and diarrhea.-Fineline Info & Tech