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Pending the European Commission’s final decision, nipocalimab could be 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 CHMP opinion is supported by results from the Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-mg studies over 24 weeks, which demonstrated a sustained reduction in immunoglobulin G (IgG) levels, one of the root causes of autoantibody diseases

Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >75%, including autoantibodies, potentially without affecting other immune functions

Oral presentation features new data from the 24-week pivotal Vivacity-MG3 study which show sustained disease control through treatment with nipocalimab on the clinician-assessed QMGa score in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab data demonstrate longer-term sustained disease control as measured by MG-ADLb and QMG scores from the ongoing open-label extension (OLE) of the Vivacity-MG3 study Johnson & Johnson filed a Biologics License Application (BLA) for nipocalimab in August 2024 and was granted U.S. FDA Priority Review for the treatment of gMG Real-world studies highlight the unmet need of patients living with gMG, including those who are pregnant or receiving steroids

Sjögren’s disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks the fourth nipocalimab FDA Fast Track designation

The first FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab demonstrated a sustained reduction in autoantibody levels, one of the underlying causes of gMG, by up to 75% over a period of 24 weeks The investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

Patients share experiences of confusion, fear and fragmented care in managing pregnancies at risk for hemolytic disease of the fetus and newborn (HDFN) or fetal neonatal alloimmune thrombocytopenia (FNAIT) under current standard of care These patient perspectives highlight the gap that remains for treatments that address the significant unmet need in life-threatening immune-mediated conditions during pregnancy The Phase 3 AZALEA, FREESIA-1 and FREESIA-3 clinical studies of nipocalimab, an investigational FcRn blocker, are enrolling pregnant individuals at risk for severe HDFN and FNAIT

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study 45% of the patients receiving steroids at open-label extension baseline were able to decrease or discontinue their steroid use Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMGb response versus placebo plus SOC in the 24-week double blind phase of the study

First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG patients taking IMAAVY demonstrated 20 months of lasting disease control and symptom relief in the pivotal Vivacity-MG3 study and ongoing open-label extension (OLE)

Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4