JnJ gets positive CHMP opinion of nipocalimab for antibody-positive patients living with generalised myasthenia gravis
Beerse: Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of nipocalimab, a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG).
The recommendation is for nipocalimab in a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive.
“Results from the Phase 3 Vivacity-MG3 trial demonstrate nipocalimab has the potential to offer sustained disease control in a condition that is associated with fluctuations in symptoms,” said Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “Today’s positive CHMP opinion is a vital step forward in our unwavering commitment to improve the treatment landscape for people living with generalised myasthenia gravis across Europe. We look forward to the European Commission’s decision, which brings us closer to delivering an innovative treatment option to those who need it most.”
gMG is a chronic, incurable autoantibody disease that affects approximately 56,000 to 123,000 people across Europe. Patients often experience debilitating symptoms such as muscle weakness, difficulty chewing, swallowing, speaking, and breathing that severely disrupt their ability to carry out even the most basic daily activities, such as going for a walk. There still exists an immense need for additional immune-selective treatment options that can offer sustained disease control and tolerability for people living gMG.
The CHMP recommendation for nipocalimab is supported by data from the pivotal, ongoing Phase 3 Vivacity-MG3 study which showed that outcomes for anti-AChR and anti-MuSK antibody-positive adult participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC. The primary endpoint of the study measured improvement in the MG-ADL score from baseline over 24 weeks and study participants included anti-AChR, anti-MuSK, and anti-LRP4 antibody-positive adults, which account for approximately 95% of the gMG patient population. Patients who entered the open-label extension (OLE) phase after the double-blind phase and continued nipocalimab treatment, maintained improvements in the MG-ADL score for up to 84 weeks, making Vivacity-MG3 the first registrational study to demonstrate sustained disease control over this duration. Safety and tolerability were consistent with other nipocalimab studies.
The recommendation also included data from the Phase 2/3 Vibrance-mg study of nipocalimab in anti-AChR antibody-positive adolescents (aged 12 – 17 years) living with gMG.2 Study participants who were treated with nipocalimab plus SOC achieved sustained disease control as measured by the primary endpoint of IgG reduction from baseline over 24 weeks compared to placebo plus SOC, and secondary endpoints of improvement in MG-ADL and QMG scores. Nipocalimab was well-tolerated over the six-month period, similar to tolerability seen in adult participants in the Vivacity-MG3 study.
The CHMP opinion is the response to a Marketing Authorisation Application (MAA) submitted to the European Medicines Agency (EMA) for nipocalimab in gMG in September 2024. The European Commission will review the CHMP recommendation and provide a decision in due course.
