The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.

Phase III Vivacity-MG3 trial shows that nipocalimab, an investigational FcRn blocker, significantly the improves symptoms of generalized myasthenia gravis with a manageable safety profile.

Please provide your email address to receive an email when new articles are posted on . The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals ...

Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4 SPRING HOUSE, Pa., Jan. 9, 2025 /PRNewswire ...

Findings showed nipocalimab plus standard of care (SOC) improved MG-ADL score from baseline by 4.70 points compared with 3.25 points with placebo plus SOC over weeks 22, 23, and 24. The Food and ...

Jan. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics ... patients with generalized myasthenia gravis (gMG), as supported by findings from the ...

Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis. The New Brunswick ...

Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis. The FDA has granted Priority Review to a Biologics License ...