Johnson & Johnson receives FDA approval for IMAAVY, a new FcRn blocker for generalized myasthenia gravis.

Johnson & Johnson has received FDA approval for IMAAVY (nipocalimab-aahu), a new FcRn blocker for generalized myasthenia gravis (gMG). The treatment is approved for anti-AChR and anti-MuSK antibody positive adults and pediatric patients aged 12 and older, and demonstrated rapid and substantial reduction in IgG levels in both adult and pediatric pivotal studies. gMG patients taking IMAAVY showed 20 months of lasting disease control and symptom relief.

Johnson & Johnson (NYSE: JNJ) has announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, following FDA Priority Review designation, offers a new treatment option for adults and pediatric patients aged 12 and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.

The approval is supported by data from the pivotal Vivacity-MG3 study, which demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care (SOC), as measured by improvement in the MG-ADL score. This translates into patients regaining essential daily functions such as chewing, swallowing, speaking, and breathing. Participants on IMAAVY plus SOC maintained improvements out to 20 months of follow-up in the ongoing open-label extension (OLE) study in gMG.

IMAAVY™ demonstrated a rapid and sustained reduction in autoantibody levels by up to 75% from the first dose and throughout a 24-week period of monitoring. Results from the ongoing Vibrance Phase 2/3 pediatric study in adolescents aged 12-17 years showed that IMAAVY plus SOC met its primary endpoint with a 69% reduction in total serum IgG over 24 weeks.

The approval of IMAAVY™ marks a significant milestone for the more than 240 million patients suffering from autoantibody diseases, many with few or no approved targeted treatments. Johnson & Johnson is committed to supporting affordable access to all its treatments, including offering a patient support program called IMAAVY withMe in the United States. With this program, commercially insured patients who are prescribed IMAAVY may be eligible to receive their first treatment in as quickly as one week and may pay as little as $0 per infusion.

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

References:
[1] https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg