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# FDA OKs J&J’s Imaavy for Myasthenia Gravis
- URL: https://www.fdaweb.com/fda-oks-j-js-imaavy-for-myasthenia-gravis/
- Published: 2025-04-30T12:00:00.000Z
- Updated: 2026-09-14T15:10:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159090

FDA has approved a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody for treating generalized myasthenia gravis. The company describes the therapy as an immunoselective therapy designed to “substantially reduce immunoglobulin G (IgG), including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions.”

Approval is based on data from the pivotal, ongoing Vivacity-MG3 study showed that Imaavy plus standard of care (SOC) provided “superior disease control throughout 24 weeks when compared to placebo plus SOC,” J&J says. It also 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, it adds.

Regarding safety, the company says Imaavy demonstrated a “consistent safety profile across both Vivacity-MG3 and the ongoing Vibrance-MG studies, with comparable tolerability in adult and pediatric populations.”