Johnson & Johnson (NYSE: JNJ), a leading healthcare company based in the U.S., has reported a second New Drug Application (NDA) filing for its FcRn blocker, nipocalimab. The company has submitted the application to the European Medicines Agency (EMA) for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for specific antibodies.
This follows a previous filing with the U.S. Food and Drug Administration (FDA) for the same indication last month. Both applications are supported by the positive results from the Phase III Vivacity-MG3 study, which included adult gMG patients positive for anti-AChR, anti-MuSK, and anti-LRP4b antibodies, representing approximately 95% of the gMG patient population. The study demonstrated that treatment with nipocalimab, in addition to the standard of care (SOC), achieved a significant improvement in the MG-ADLa score over 24 weeks compared to placebo plus SOC.
Johnson & Johnson is aiming for nipocalimab to establish a distinct position in the market, differentiating itself from ArgenX SE’s (Nasdaq: ARGX) Vyvgart (efgartigimod alfa), the first-in-class FcRn-targeted therapy approved for myasthenia gravis in 2021, and UCB’s Rystiggo (rozanolixizumab), which received approval in 2023. – Flcube.com
