FDA Approves Johnson & Johnson's Imaavy for gMG Treatment

Johnson & Johnson has received FDA approval for Imaavy (nipocalimab), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG) in patients aged 12 and older. Backed by the pivotal Vivacity-MG3 study, Imaavy demonstrated superior disease control compared to placebo when combined with standard care. The approval addresses a significant unmet need for patients with anti-AChR or anti-MuSK antibody positive gMG, who make up the vast majority of antibody-positive cases. With this approval, Johnson & Johnson strengthens its competitive position in a market currently led by Argenx’s Vyvgart. The drug offers a new treatment option that may provide lasting disease stability and improved quality of life for people living with gMG. The FDA’s decision follows a priority review, reflecting the therapy's potential to meet critical patient needs.