Innovative Medicine

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

100 percent of evaluable patients achieved minimal residual disease (MRD) negativity Updated Phase 2 MajesTEC-5 results underscore the importance of additional treatment options earlier in the disease

Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new standard for treating patients with moderate-to-severe plaque psoriasis

First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1 Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal

Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, surpassing monotherapy TKI osimertinib by more than one year

RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment

Updated MARIPOSA analysis at WCLC shows combination prevents common EGFR and MET resistance, helping patients live longer Additional study results highlight strategies to reduce dermatologic reactions and simplify administration with once-monthly subcutaneous dosing

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

Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2