Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) to authorise the use of nipocalimab for the treatment of generalised myasthenia gravis (gMG).
As per the 29 August press release, the BLA was supported by data from VIVACITY-MG3, a Phase III study (NCT04951622) designed to evaluate the safety and efficacy of biweekly nipocalimab in adult patients with gMG. The randomised, double-blind, placebo-controlled study enrolled 199 participants with antibody positive or antibody negative gMG that demonstrated an insufficient response to standard of care treatment. Of the total enrolment, 153 participants were antibody positive.
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Back in February, J&J announced that the Phase III trial met its primary endpoint by demonstrating a statistically significant reduction on the myasthenia gravis activities of daily living scale (MG-ADL) from baseline over a period of 22–24 weeks compared to placebo. A key secondary endpoint included a change in Quantitative Myasthenia Gravis (QMG) score, a 13-item physician assessment that quantifies disease severity based on impairments in body functions and structures.
Among the secondary endpoints were also assessments of adverse events. The study reported that the safety and tolerability profile of nipocalimab was consistent with other studies of the therapy.
“We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalised myasthenia gravis, a chronic, life-long disease,” said Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine Bill Martin, Ph.D, in the press release.
In gMG, a rare and chronic autoimmune disorder, autoantibodies target proteins at the neuromuscular junction, disrupting signaling between nerves and muscles and driving progressive weakening of the body’s voluntary muscles.
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By GlobalDataNipocalimab is an IgG receptor FcRn large subunit p51 antagonist designed to block the neonatal Fc receptor. As FcRn inhibitors prevent IgG from binding to FcRn, the IgG receptor is subsequently degraded, and this results in a rapid decrease in IgG levels. The monoclonal antibody is also being evaluated for the treatment of haemolytic disease of the foetus and newborn (HDFN), rheumatoid arthritis, and Sjogren’s disease.
In February 2024, the FDA awarded a breakthrough therapy designation to nipocalimab for the treatment of alloimmunised pregnant people at increased risk of increased severe HDFN.
According to GlobalData’s consensus forecast, nipocalimab is anticipated to yield global sales of $1.8bn in 2030. GlobalData is the parent company of Pharmaceutical Technology.
