Johnson & Johnson Submits BLA for FcRn Antibody Nipocalimab in Generalized Myasthenia Gravis

▎Armstrong

On August 29, 2024, Johnson & Johnson announced that it had submitted a marketing application to the FDA for the FcRn antibody Nipocalimab, intended for the treatment of patients with generalized myasthenia gravis. This application is based on data from the Phase III clinical trial Vivacity-MG3.

On August 1, 2020, Johnson & Johnson acquired Momenta, a biotechnology company, for $6.5 billion, obtaining the autoimmune R&D pipeline including Nipocalimab (which was in Phase III clinical stage at the time, with the R&D pipeline as follows).

In the Phase III clinical trial Vivacity-MG3, after 24 weeks of treatment, the Myasthenia Gravis Activities of Daily Living scale (MG-ADL) scores decreased by 4.70 in the Nipocalimab + standard therapy group and by 3.25 in the placebo + standard therapy group, with a difference of 2.45 and a p-value of 0.002. The Quantitative Myasthenia Gravis scale (QMG) scores decreased by 4.86 and 2.05, respectively, with a difference of 2.81 and a p-value less than 0.001.

Secondary Endpoint: Nipocalimab + Standard Therapy Demonstrates Faster, Deeper, and More Durable Treatment Response.

Summary

Argenx's Efgartigimod is the first marketed FcRn-targeting drug, with sales reaching $1.2 billion in 2023 and $876 million in the first half of this year, achieved solely from the gMG indication. In China, Zai Lab has acquired the Greater China rights to Efgartigimod, while Harbour BioMed's Batoclimab has resubmitted its marketing application.