Johnson & Johnson (J&J) has received approval from the US Food and Drug Administration for its FcRn blocker Imaavy (nipocalimab-aahu) in generalised myasthenia gravis (gMG).
The drug has been authorised to treat the rare autoimmune disease in adults and paediatric patients aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
In myasthenia gravis, autoantibodies target proteins at the neuromuscular junction, disrupting the ability of the nerves to stimulate the muscles. The disease affects an estimated 700,000 people worldwide, with 85% of these patients experiencing the more extensive form of the disease, gMG.
J&J’s Imaavy is designed to block FcRn and reduce levels of circulating immunoglobulin G antibodies that underlie gMG.
The FDA’s decision on the drug was based on results from the phase 3 Vivacity-MG3 study, in which adult gMG patients receiving Imaavy plus standard of care achieved superior disease control throughout 24 weeks, as measured by improvements in the MG-ADL score, compared to those randomised to receive placebo plus standard of care.
Data from an ongoing open-label extension phase of the trial showed that patients in the Imaavy cohort maintained improvements out to 20 months of follow-up, J&J said, adding that Imaavy was associated with a “rapid and sustained” reduction in autoantibody levels by up to 75% from the first dose and throughout a 24-week period of monitoring.
Positive results from the ongoing phase 2/3 Vibrance in anti-AChR and anti-MuSK antibody-positive patients aged 12 to 17 years also supported the authorisation.
David Lee, global immunology therapeutic area head, J&J Innovative Medicine, said: “This approval is the result of years of scientific commitment, collaboration and determination for our nipocalimab programme, and we’re proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.”
Beyond gMG, nipocalimab is being evaluated across three key segments in the autoantibody space: rare autoantibody diseases, rheumatic diseases and certain maternal foetal diseases.
The drug has already received several key designations by the FDA, including breakthrough therapy designation as a treatment for adults with moderate-to-severe cases of the chronic autoimmune disorder, Sjögren’s disease.
