Johnson & Johnson has announced that the European Commission (EC) has approved IMAAVY® (nipocalimab) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG).1
What this approval means for patients:
- Nipocalimab is the first FcRn blocker approved in Europe for both adult and adolescent patients with gMG aged 12 and older who areanti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.1,2,3
- Targeted mechanism of action: data from the pivotal phase 3 Vivacity-MG3 study in adults, and the phase 2/3 Vibrance-MG study in adolescents, demonstrated treatment with nipocalimab and standard of care (SOC) delivered a rapid and substantial reduction in immunoglobulin-G (IgG) levels, a root cause of gMG.2,3 Nipocalimab is a monoclonal antibody designed to block FcRn and reduce IgG levels, without additional detectable effects on other adaptive and innate immune functions.4
- Potential for improved sustained disease control: patients in the pivotal Vivacity-MG3 study and ongoing open-label extension (OLE) treated with nipocalimab plus SOC demonstrated up to 20-months of sustained disease control and symptom relief.2,5
An estimated 56,000 to 123,000 people across Europe are affected by gMG – a chronic, incurable autoantibody disease that causes severe muscle weakness and difficulties with speaking, swallowing and breathing, and for which treatment choices currently remain limited for vulnerable populations, such as adolescents.6,7,8,9
This approval is supported by the data from the pivotal, ongoing phase 3 Vivacity-MG3 study which showed patients who received nipocalimab plus standard of care (SOC) had superior disease control compared to those who received placebo plus SOC throughout 24 weeks.6,c,d The primary endpoint of the study measured improvement in the MG-ADLc score from baseline over 24 weeks across study participants which included anti-AChR, anti-MuSK, and anti-low density lipoprotein-related protein 4 [LRP4] antibody-positive adults.6 Patients who entered the open-label extension (OLE) phase of Vivacity-MG3 and continued their treatment with nipocalimab, maintained improvements for up to 20 months of follow-up, and demonstrated sustained disease control over this long duration.[9] Safety and tolerability were consistent with other nipocalimab studies.[10],[11],[12],e The overall incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to discontinuation were similar to that in the placebo plus SOC group.6,9,e
This approval also includes data from the phase 2/3 Vibrance-MG study of nipocalimab in anti-AChR antibody-positive adolescents (aged 12–17 years) living with gMG.7 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-ADLc and QMGf scores.7 Nipocalimab was well-tolerated over the six-month period, with tolerability similar to that seen in adult participants in the Vivacity-MG3 study.6,7
Nipocalimab is already approved in the US, Brazil and Japan for the treatment of gMG, with further health authority submissions currently under review worldwide.
References supplied.
