JnJ seeks approval of nipocalimab to treat generalized myasthenia gravis

Spring House: Johnson & Johnson has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis (gMG).

The application included data from the Phase 3 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 score from baseline over 24 weeks and study participants included anti-AChR+, anti-MuSK+, and anti-LRP4+ 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.

“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, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “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.”

Nipocalimab is a 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 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 G (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.

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Initial disease manifestations are usually ocular but in 85 percent or more cases, the disease generalizes (gMG), which is characterized by fluctuating weakness of the skeletal muscles leading to symptoms like limb weakness, drooping eyelids, double vision and difficulties with chewing, swallowing, speech, and breathing. Approximately 100,000 individuals in the U.S. are living with gMG. Although gMG may be managed with current conventional therapies, new therapies are needed for those who may not respond well enough to or tolerate these options.