Ultomiris, the generalised myasthenia gravis (gMG) treatment developed by multinational pharmaceutical giant AstraZeneca PLC (LSE:AZN), has been approved for adult treatment in Europe.
The nod from the European Commission marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of the debilitating autoimmune disease.
The FTSE 100 company’s treatment gained a positive opinion from the Committee for Medicinal Products for Human Use based on results from the CHAMPION-MG Phase III trial.
Commenting on the approval, professor Renato Mantegazza at Carlo Besta Neurological Institute’s Department of Neuroimmunology and Neuromuscular Diseases, said: "As physicians, we see first-hand how gMG can have a debilitating impact on quality of life.
“Today's approval is a major advancement for treating gMG in Europe, offering patients and physicians a new, long-acting treatment option which has shown reliable efficacy and sustained improvements in activities of daily living."
Ultomiris was approved in the US in April 2022 and Japan in August 2022 for certain adults with gMG. Regulatory reviews are ongoing in additional countries.