The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s IMAAVY (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (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 (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive).

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. Anti-AChR and anti-MuSK antibody positive individuals comprise ≥90% of the total antibody-positive gMG population. IMAAVY is designed to substantially reduce immunoglobulin G (IgG), 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 – the longest primary endpoint of a registrational trial of any FcRn blocker in adults with living with gMG.

“Today’s FDA approval of IMAAVY marks a historic milestone for the more than 240 million patients suffering with autoantibody diseases, many with few or no approved targeted treatments,” said David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “This approval is the result of years of scientific commitment, collaboration and determination for our nipocalimab program, and we’re proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.”

Health authority submissions seeking approval for nipocalimab in the treatment of gMG are currently under review with numerous regulatory authorities worldwide.