Johnson & Johnson seeks initial approval of nipocalimab to treat the broadest population with antibody-positive generalized myasthenia gravis

Johnson & Johnson seeks initial approval of nipocalimab to treat the broadest population with antibody-positive generalized myasthenia gravis

Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking the first global approval of nipocalimab for the treatment of people with generalized myasthenia gravis (GMG).

The application included data from the phase 3 Vivacity-MG3 trial, 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 study's primary endpoint measured improvement in MG-ADLA score from baseline over 24 weeks, and study participants included anti-AChR+, anti-Musk+, and anti-LRP4+B antibody-positive adults, representing approximately 95 percent of the GMG patient population who received Vivacity-mg3 for the first and only study to combat persistent Disease control in these subtypes.[1]Present[2] Safety and tolerability were consistent with other nipocalimab studies.[3]Present[4]Present[5]

“We are encouraged by the potential of nipocalimab to provide sustained disease control for people with generalized myasthenia gravis, a chronic, lifelong disease,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "The Nipocalimab approval submission represents an important step forward as Johnson & Johnson continues to push the boundaries of research to develop innovative solutions to treat autoantibody-driven diseases and build on decades of expertise in neuroscience and immunology. We look forward to working with the FDA in reviewing the data supporting the submission."

Nipocalimab is the first FCRN blocker to demonstrate control of persistent disease, as measured by improvement in MG-ADL, when added to background SOC compared to placebo plus SOC over six months of consistent dosing (every other week) C what is what is. The longest period of controlled safety and efficacy evaluation of an FCRN blocker in GMG.

Earlier this year, Johnson & Johnson presented data focused on the molecular properties of nipocalimab at the annual meeting of the American Academy of Neurology. Properties 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.[6] These properties, along with the dosage regimen selected for the study, are believed to lower IgG, including IgG autoantibodies in diseases such as GMG and other autoantibody-driven diseases.[7]

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