The FDA has approved Johnson & Johnson’s anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis (gMG). This myasthenia gravis drug will be marketed under the name IMAAVY. Although J&J isn’t the first to receive FDA approval for an FcRn-blocking antibody in this indication, the company is optimistic that IMAAVY’s broad label will help secure a strong foothold in the FcRN inhibitors market over time.
With this approval, J&J enters a generalized myasthenia gravis competitive landscape alongside established players such as AstraZeneca, which markets SOLIRIS and ULTOMIRIS, as well as Argenx’s VYVGART and UCB’s RYSTIGGO and ZILBRY...
