The US FDA has approved nipocalimab-aahu for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 years and older who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Nipocalimab is a neonatal fragment crystallizable receptor (FcRn) blocker that reduces circulating immunoglobulin G (IgG) levels. Clinical evidence In a clinical trial involving 196 patients, the nipocalimab-aahu significantly improved Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores compared to placebo over 24 weeks.
In an ongoing clinical trial, nipocalimab plus standard of care sustained improvements in MG-ADL scores for up to 20 months. Additionally, it reduced autoantibody levels by up to 75% over 24 weeks. Dosage and administration Available for intravenous infusion Evaluate the need…
