Thursday, Johnson & Johnson (NYSE:JNJ) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized myasthenia gravis (gMG).
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels.
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The application included data from the Phase 3 Vivacity-MG3 study, which showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 compared with placebo.
Earlier this year, at the American Academy of Neurology Annual Meeting, Johnson & Johnson presented data on the molecular properties of nipocalimab.
Last year, the FDA approved UCB SA's (OTC:UCBJF) (OTC:UCBJY)
Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
The company says Rystiggo is the only FDA-approved treatment in adults for anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
Johnson & Johnson's drug will also compete with Argenx SE's (NASDAQ:ARGX) Vyvgart Hytrulo for gMG in adult patients who are anti-acetylcholine receptor antibody positive.
The drug is available in subcutaneous and intravenous injections.
Price Action: JNJ stock is up 0.36% at $164.51 at the last check on Thursday.
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