Submission of nipocalimab to the FDA to treat broadest population living with antibody positive generalized myasthenia gravis

The application included data from the Phase III 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. The primary endpoint of the study measured improvement in the MG-ADL a score from baseline over 24 weeks and study participants included anti-AChR+, anti-MuSK+, and anti-LRP4+b antibody positive adults, which account for approximately 95 percent of the gMG patient population, making Vivacity-MG3 the first-and-only study to demonstrate sustained disease control in these subtypes. Safety and tolerability were consistent with other nipocalimab studies.

Nipocalimab is the first-and-only FcRn blocker to demonstrate sustained disease control measured by improvement in MG-ADL when added to background SOC compared with placebo plus SOC over a period of six months of consistent dosing (every other week), which is the longest period of controlled safety and efficacy assessment of an FcRn blocker in gMG.

Earlier this year (2024) at the American Academy of Neurology Annual Meeting, Johnson & Johnson presented data focused on the molecular properties of nipocalimab. Characteristics such as its high binding affinity and specificity to the immunoglobulin (IgG) binding site of FcRn have the potential to differentiate nipocalimab in the FcRn blocker class of treatments. These properties, along with the dosing regimen chosen for the study, are thought to lower IgG, including IgG autoantibodies in diseases such as gMG and other autoantibody-driven diseases.

Editor’s notes: a. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient’s recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity. b. Positive patients include anti-acetylcholine receptor positive antibody (AChR+), anti-muscle specific tyrosine kinase positive antibody (MuSK+) and/or anti-low density lipoprotein receptor-related protein 4 positive antibody (LRP4+).c. Patients who received nipocalimab plus current SOC had a mean change of -4.70 [standard error (SE) 0.329]. Patients on placebo plus current SOC had a mean change of -3.25 (SE 0.335); difference of least-squares (LS) means -1.45 [0.470]; P=0.002.