The FDA has approved a new drug called Ultomiris (ravulizumab-cwvz) for adults with generalized myasthenia gravis (gMG) who test positive for a specific antibody called anti-acetylcholine receptor (AChR). This is a chronic autoimmune disease that causes muscle weakness that can come and go. Ultomiris works by blocking part of the immune system called complement, which can damage the connection between nerves and muscles.
This approval is for patients whose gMG is caused by AChR antibodies. It is given as an intravenous (IV) infusion. The dose is based on body weight and is given every 8 weeks after a first larger dose. The approval was based on clinical trials that showed the drug is effective and safe for this group of patients.
This new option may help people with AChR antibody-positive gMG manage their symptoms. However, it is not a cure. Patients should talk to their doctor to see if Ultomiris is right for them. As with any new treatment, it is important to discuss potential benefits and risks with a healthcare provider.