Johnson & Johnson Submits Biologics License Application for Nipocalimab in Patients with Antibody-Positive Generalized Myasthenia Gravis

Image Credit: Adobe Stock Images/Катерина Євтехова

Johnson & Johnson (J&J) announced that it has submitted a Biologics License Application (BLA) to the FDA for approval of nipocalimab in treating antibody-positive generalized myasthenia gravis (gMG). According to the company, the Phase III Vivacity-MG3 study, which was the first to show sustained disease control across key gMG subtypes, supported J&J’s decision to submit the BLA.¹

“We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalized myasthenia gravis, a chronic, life-long disease,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, in a press release. “The filing for approval of nipocalimab represents an important step forward as Johnson & Johnson continues to push the boundaries of research to develop innovative solutions to treat autoantibody-driven diseases, building on decades of expertise in neuroscience and immunology. We look forward to working with the FDA in their review of the data supporting the submission.”

The Vivacity-MG3 study was a 24-week double-blind placebo-controlled trial. Consisting of 199 patients, 153 were identified as antibody positive. The patients were randomized 1:1 to receive nipocalimab plus current standard-of-care (SOC) (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC. The primary endpoint of the study measured improvement in the MG-ADL from baseline over 24 weeks and study participants included anti-AChR+, anti-MuSK+, and anti-LRP4+ antibody positive adults. The secondary endpoint was a change in Quantitative Myasthenia Gravis (QMG) score, which is a 13-item assessment by a clinician that quantifies MG disease severity.¹

Results of the trial found that patients who received nipocalimab plus SOC improved by 4.70 points on the MG-ADL, significantly more than the 3.25-point improvement from baseline observed with placebo plus SOC from baseline over Weeks 22, 23 and 24. Additionally, significant improvement was demonstrated in a number of muscle groups, as measured by QMG.

Safety and tolerability were consistent with previous nipocalimab studies. Further, the overall incidence of adverse events (AEs), serious AEs, and AEs leading to discontinuation was similar to that in the placebo plus current SOC group.²

“Myasthenia gravis can affect people of all races and ethnic backgrounds; however, it is slightly more common in people of African descent,” reports the Myasthenia Gravis Foundation of America. “Certain characteristics of myasthenia gravis can also vary depending on ethnic background. For example, research has shown that if you are of African American descent, you may be more likely to develop myasthenia gravis at a younger age and may be more likely to have a specific type of antibody called muscle-specific tyrosine kinase (MuSK) antibodies than people who are Caucasian.”

According to the Myasthenia Gravis Foundation of America, anywhere from 150 to 200 million people are currently living with MG. In the United States, an estimated 37 out of 100,000 people have MG. Current estimates suggest that a growing number of people are living with MG, possibly due to a growing population and a longer estimated lifespan. It is most common in women under 50 years old and men over 65 years old.³

“The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis,” said Carlo Antozzi, MD, neuroimmunology, muscle pathology unit, the Neurological Institute Foundation C. Besta of Milan, Italy, in a press release. “We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis.”

References

1. Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis. Johnson & Johnson. August 29, 2024. Accessed August 30, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-approval-of-nipocalimab-to-treat-broadest-population-living-with-antibody-positive-generalized-myasthenia-gravis

2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. Johnson & Johnson. June 28, 2024. Accessed August 30, 2024. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class

3. OVERVIEW OF MG. MGFA. Accessed August 30, 2024. https://myasthenia.org/Understanding-MG/Overview-of-MG#:~:text=Globally%2C%20approximately%20150%20to%20200,million%20people%20have%20myasthenia%20gravis.&text=In%20the%20US%2C%20it%20is,100%2C000%20people%20have%20myasthenia%20gravis.