Press releases

The EPIC study will evaluate treatment with IMAAVY™ versus efgartigimod in adults with gMG and will include a treatment-switch arm The Company also announced new data from the pivotal Vibrance-MG study in which pediatric patients receiving treatment with IMAAVY™ demonstrated 72 weeks of sustained reduction in immunoglobulin G (IgG), sustained disease control and no new safety concerns IMAAVY™ is the only FcRn blocker for anti-AChR and anti-MuSK antibody positive adult and pediatric gMG patients aged 12 and older that has demonstrated sustained disease control

Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score, which is based on 11 key systemic disease domains, at Week 24 versus placebo Critical patient-reported SjD symptoms including dryness, pain and fatigue trended towards greater improvement in the nipocalimab-treated group compared to placebo-treated patients Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation (BTD) by U.S. FDA for the treatment of adults living with moderate-to-severe SjD, and the Phase 3 DAFFODIL study is currently enrolling patients

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

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis

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)