Johnson & Johnson Submits BLA for Nipocalimab, a FcRn-Targeting Monoclonal Antibody Acquired for $6.5 Billion, Seeking First Global Approval in Generalized Myasthenia Gravis
Johnson & Johnson
Medical Device R&D and Manufacturer
On August 29, Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the FDA, seeking approval for the first time globally.FcRn Monoclonal AntibodyNipocalimab for the treatment of systemicSevere/CriticalPatients with myasthenia gravis (gMG).
In June this year, the Phase III VIVACITY-MG3 study of nipocalimab for the treatment of gMG reported positive results. The improvement in MG-ADL scores from baseline within 24 weeks in the group receiving the drug combined with standard of care (SOC) was superior to that in the placebo plus SOC group, achieving the primary endpoint.
This double-blind, placebo-controlled study enrolled a large number of AChR+, MuSK+, and/or LRP4+ patients, accounting for approximately 95% of the total gMG patient population. Patients receiving Nipocalimab + SOC at weeks 22, 23, and 24 showed a 4.70-point improvement in MG-ADL from baseline, significantly higher than the 3.25 points in the placebo + SOC group (P = 0.002). For individuals with gMG, a 1 to 2-point change in MG-ADL could mean the difference between normal eating and frequently choking on food, or between shortness of breath at rest and the need for a ventilator.
The study also met several key secondary endpoints:
At weeks 22 and 24, improvements in strength and function of various muscle groups measured by QMG showed significant improvement (P<0.001) in the Nipocalimab+SOC group compared to the placebo+SOC group. At weeks 22, 23, and 24, the MG-ADL response (≥2-point improvement from baseline) was significantly higher with Nipocalimab+SOC compared to placebo+SOC (P=0.021), further highlighting Nipocalimab's potential to reduce the impact of gMG on patients' daily lives.
Nipocalimab is a high-affinity, fully human, glycosylated, effector-null monoclonal antibody that selectively blocks FcRn to reduce levels of circulating immunoglobulin G (IgG) antibodies, including pathogenic autoantibodies and alloantibodies.
Nipocalimab was initially developed by AnaptysBio and later sold to Momenta. In August 2020, Johnson & Johnson acquired Momenta for $6.5 billion, gaining ownership of this drug.
gMG is a chronic, lifelong, rare, and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness. Previously, two FcRn monoclonal antibodies have been approved by the FDA for marketing: Argenx/Zai Lab's efgartigimod and UCB's rozanolixizumab, both of which have been approved for the gMG indication.Efgartigimod has shown promising commercial prospects. In 2022, the first full year of its overseas launch, sales exceeded $400 million, and in 2023, it reached $1.19 billion, entering the "blockbuster" category.
