Health
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 ongoi
About this update from Johnson & Johnson
[{"type":"image","alt":"Janssen Cilag International NV","displaySize":"","headline":null,"caption":"Janssen Cilag International NV","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":57,"url":"https://media.zenfs.com/en/globenewswire.com/162e5e4bfb9f63ed2555dd2e00c88cf1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/2MtQqo3wJMdkPmsB1cKplQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTgwO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/162e5e4bfb9f63ed2555dd2e00c88cf1","width":300,"height":57}},"lazy":false},{"type":"text","content":"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","length":155,"tagName":"p"},{"type":"text","content":"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 ","length":199,"tagName":"p"},{"type":"text","content":"gMG patients taking nipocalimab demonstrated up to 20 months of sustained disease control and symptom relief in the Vivacity-MG3 study and ongoing open-label extension","length":167,"tagName":"p"},{"type":"text","content":"BEERSE, BELGIUM, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for IMAAVY® (nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG).1 gMG is a chronic, incurable autoantibody disease that causes debilitating symptoms such as muscle weakness, difficulty chewing, swallowing and speaking.2,3,4,5 This approval is for the treatment of a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody-positive.1,6,7","length":739,"tagName":"p"},{"type":"text","content":"Anti-AChR and anti-MuSK antibody-positive individuals comprise ≥90% of the total antibody-positive gMG population.6 Nipocalimab is an immunoselective therapy designed to substantially reduce immunoglobulin G (IgG), a root cause of gMG, without additional detectable effects on other adaptive and innate immune functions.8","length":321...