Johnson & Johnson receives European Commission approval of IMAAVY® (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG)
Nipocalimab is the first FcRn blocker approved in both adult and adolescent gMG patients aged 12 and older who are anti-AChR or anti-MuSK antibody-positive In the pivotal Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-MG studies over 24 weeks, nipocalimab demonstrated rapid and substantial reduction in immunoglobulin G levels, one of the root causes of gMG gMG patients taking nipocalimab demonstrated up to 20 months of sustained disease control and symptom relief in the Vivacity-MG3 study and ongoing open-lab ...