The U.S. Food and Drug Administration (FDA) has approved Imaavy (nipocalimab) for the treatment of generalized myasthenia gravis (MG). The approval is for patients, 12 years of age and older, with anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) positive antibodies.
MG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. Weakness tends to increase during periods of activity and improve after periods of rest. The condition results from a defect in the transmission of nerve impulses to muscles, which is due to the presence of antibodies against acetylcholine.
The approval follows positive data from the ongoing phase 3 Vivacity-MG3 clinical trial (NCT04951622) evaluating nipocalimab in adults with MG as well as an ongoing phase 2/3 pediatric study in adolescents aged 12-17 years. Nipocalimab is a human FcRn-blocking monoclonal antibody that targets and reduces circulating immunoglobulin G (IgG) antibody levels.
In the Vicacity-MG3 study, nipocalimab plus standard of care resulted in superior disease control through 24 weeks compared to placebo plus standard of care. Disease control was measured by improvement in MG Activities of Daily Life score. Improvements in this score indicate better ability of patients to chew, swallow, speak, and breathe. Nipocalimab plus standard of care also maintained improvements at up to 20 months of follow-up in the ongoing open-label extension study. Similar efficacy results were observed in the ongoing pediatric study.
Additionally, nipocalimab demonstrated a rapid and sustained reduction in autoantibody levels by up to 75% from first dose and through 24 weeks. Safety profiles have been favorable and consistent.
For more information, click here.
To learn more about MG and other rare neurological disorders, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/