J&J Files For FDA Approval Of Nipocalimab To Treat Generalized Myasthenia Gravis

(RTTNews) - Drug major Johnson & Johnson (JNJ) announced Thursday the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration seeking the first approval of nipocalimab globally to treat people living with generalized myasthenia gravis or gMG.

Myasthenia gravis or MG is an autoantibody disease in which autoantibodies target proteins at the neuromuscular junction, disrupt neuromuscular signaling, and impair or prevent muscle contraction.

Nipocalimab is an investigational monoclonal antibody treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies.

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 were superior compared to those who received placebo plus standard of care.

The primary endpoint of the study measured improvement in the MG-ADLa score from baseline over 24 weeks and study participants included anti-AChR+, anti-MuSK+, and anti-LRP4+b antibody positive adults, which account for around 95 percent of the gMG patient population.

The company noted that Vivacity-MG3 is 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.

The FDA and European Medicines Agency have granted several key designations to nipocalimab.

Bill Martin, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine, said, "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. 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."

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