Janssen-Cilag submits MAA to EMA for nipocalimab, an FcRn blocker for gMG, based on Phase 3 Vivacity-MG3 study results showing sustained disease control in antibody-positive patients over 24 weeks.
The 8 mg dexamethasone pre-medication regimen reduced infusion-related reaction (IRR) rates with intravenous amivantamab to 22.5%, a three-fold decrease from historical 67.4% rates.