An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Latest Information Update: 23 Feb 2026
At a glance
- Drugs Nipocalimab (Primary)
- Indications Myasthenia gravis
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms Vibrance-MG
- Sponsors Janssen Research & Development
Most Recent Events
- 17 Feb 2026 Planned End Date changed from 26 Jun 2026 to 2 Jul 2029.
- 02 Dec 2025 According to Johnson & Johnson media release, the European Commission has approved a Marketing Authorisation for IMAAVY(nipocalimab), as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). supported by the data from Vivacity-MG3 and Vibrance-MG trials.
- 29 Oct 2025 According to the Johnson and Johnson Media Release, long-term extension (LTE) data will present at the 2025 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting.