Homepage > Company > Media > Pharma News > 2024 > J&J targets generalised myasthenia gravis landscape with nipocalimab

J&J targets generalised myasthenia gravis landscape with nipocalimab

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.

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.

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.

Nipocalimab 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.

Read also

Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the Center for Drug Evaluation (CDE) of China&...

FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a...

Gilead gives up on $15M MASH bet with Yuhan after mulling preclinical data

In a year that has seen an approval and a raft of readouts for metabolic dysfunction-associated steatohepatitis (MASH), Gilead has decided to walk away from a $785 million biobucks deal in the...

FDA AdCom votes in favour of Stealth’s Barth syndrome drug

AUS Food and Drug Administration (FDA) advisory committee (AdCom) has voted in support of Stealth BioTherapeutics’ first-line Barth syndrome drug, despite a trial studying the drug n...