US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies.
This filing is supported by the Phase III Vivacity-MG3 study, which focused on adult gMG patients positive for anti-AChR+, anti-MuSK+, and anti-LRP4+b antibodies—collectively representing about 95% of the gMG patient population. The study demonstrated that treatment with nipocalimab plus standard of care (SOC) significantly improved MG-ADL scores over 24 weeks compared to placebo plus SOC.
Nipocalimab, an FcRN inhibitor, works by lowering levels of circulating immunoglobulin G (IgG) antibodies, aiming to reduce the auto- and allo-antibodies that drive various autoimmune diseases. J&J has also launched Phase III or II trials for the drug across several other indications, including warm autoimmune hemolytic anemia (WAIHA), chronic inflammatory demyelinating polyneuropathy, Sjogren’s syndrome, systemic lupus erythematosus, rheumatoid arthritis, and hemolytic disease of the fetus and newborn (HDFN). Nipocalimab was originally developed by Momenta Pharmaceuticals Inc., which J&J acquired in 2020 for USD 6.5 billion.
J&J is positioning nipocalimab to differentiate itself from competitors such as ArgenX SE’s (NASDAQ: ARGX) first-in-class FcRn-targeted Vyvgart (efgartigimod alfa) and UCB’s Rystiggo (rozanolixizumab), both of which have already been approved to treat myasthenia gravis in 2021 and 2023, respectively.- Flcube.com
