CHMP recommends Ultomiris to treat patients with generalised myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive.- AstraZeneca

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the CHAMPION-MG Phase III trial. In this trial, 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.

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 the EU is estimated at approximately 89,000.

Renato Mantegazza, Professor at the Department of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy, and CHAMPION-MG trial investigator, said: “gMG is a rare and complex disorder that requires early, consistent and reliable intervention. This positive recommendation offers hope to the community for an effective long-acting option that will require fewer treatments each year and help improve disease management".