J&J biologic Imaavy achieves EU first in generalised myasthenia gravis

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Johnson & Johnson’s immunoselective monoclonal antibody Imaavy (nipocalimab) has been approved by the European Commission to treat individuals with generalised myasthenia gravis (gMG) 12 years old and over.

The decision covers the biologic’s use as an add-on to standard therapy for eligible anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive patients and makes it the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.

Professor Andreas Meisel, Charité – Universitätsmedizin Berlin, said that with the approval of nipocalimab, “we now have an important new treatment option for a broad range of antibody-positive people living with generalised myasthenia gravis (gMG).

“This decision reflects a major advance in therapeutic approaches designed to enhance symptom control and the long-term management of gMG both in adolescents and adults.”

In total, 90 percent or more of the antibody-positive gMG population comprise of patients with the anti-AChR and anti-MuSK antibody-positive forms of the immune condition.

The approval was supported by data from the ongoing phase III Vivacity-MG3 trial showing Imaavy plus standard of care enabled superior disease control compared to placebo plus standard of care throughout 24 weeks. 

In this trial and the phase II/III Vibrance-MG study, Imaavy also demonstrated a rapid and significant reduction in immunoglobulin G levels, a root cause of gMG.

Other than its main mechanism of action of significantly depleting immunoglobulin G levels, the drug is designed to have no additional detectable effects on other adaptive and innate immune functions.

Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA, said: “The approval of nipocalimab as the first FcRn blocker to treat a broad population of adults and adolescents living with gMG marks a meaningful advance in addressing persisting unmet needs and supporting more consistent, long-term disease management for patients.”

This latest approval by the EC follows its decision last year to approve UCB’s Rystiggo (rozanolixizumab) as the first therapy for adults with AChR or MuSK antibody positive gMG. Like Imaavy, UCB’s therapy was authorised as an add-on to standard treatment.