Johnson & Johnson receives FDA approval for Imaavy in myasthenia gravis

Johnson & Johnson announced that the FDA has approved Imaavy – nipocalimab-aahu -, a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis, or gMG. The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG. gMG is a chronic, debilitating autoantibody disease for which significant unmet patient need exists for additional efficacious therapies with demonstrated safety profiles that offer sustained disease control. Imaavy is an immunoselective therapy designed to substantially reduce immunoglobulin G, including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions. The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study. Imaavy plus standard of care provided superior disease control throughout 24 weeks when compared to placebo plus SOC. Imaavy has demonstrated a consistent safety profile across both Vivacity-MG3 and the ongoing Vibrance-MG studies, with comparable tolerability in adult and pediatric populations. Health authority submissions seeking approval for nipocalimab in the treatment of gMG are currently under review with numerous regulatory authorities worldwide.