On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. J&J submitted a Biologics Licence Application (BLA) to the FDA seeking approval for this indication in August 2024.
This news follows J&J’s announcement in November 2024 that the US FDA granted Breakthrough Therapy Designation for nipocalimab for the treatment of moderate-to-severe Sjögren’s disease.