On 11 November 2024, Johnson & Johnson (J&J) announced that the US FDA has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren’s disease (SjD). This makes nipocalimab the only investigational therapy to receive this designation in SjD. Currently, there are no approved advanced treatments available for SjD.
This news follows J&J’s announcement in October 2024 of positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRa positive adolescents (aged 12 – 17 years) living with generalised myasthenia gravis (gMG), which demonstrated sustained disease control over 24 weeks. In August 2024, J&J submitted a Biologics License Application (BLA) to the FDA seeking approval of nipocalimab globally for the treatment of people living with gMG.