EMEA Search Results

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-label extension

Guselkumab offers the flexibility of self-administration from the start of treatment in both ulcerative colitis (UC) and Crohn’s disease (CD),1,2,3 providing the simplicity of a fully subcutaneous dose regimen in both diseases2,4 Guselkumab achieved significant rates of clinical remissiona and endoscopic healingb versus placebo at Week 12 with a subcutaneous induction dose regimen in UC,2,5 consistent with intravenous induction2,6

Responses were rapid and durable, and tumour shrinkage was observed in 82 percent of patients1 New findings from this investigational study build on the strength of the data for amivantamab in non-small cell lung cancer and broadens its potential across additional solid tumours1,2

17 abstracts from across the Company’s portfolio and pipeline highlight new clinical and real-world data on major depressive disorder and treatment-resistant depression New post-hoc analysis of lumateperone Phase 3 data evaluates the impact on sexual function in MDD, reinforcing potential to reset treatment expectations European Union and United Kingdom sub-group analyses of Phase 3 data evaluates efficacy of adjunctive seltorexant compared to adjunctive quetiapine XR in MDD with insomnia symptoms New data from post-hoc analysis of ESCAPE-TRD explores association of patient characteristics and remission with SPRAVATO® (esketamine nasal spray) versus quetiapine XR in treatment-resistant depression

Recommendation based on the findings from the Phase 3 ASTRO study in ulcerative colitis.1,2,3 Guselkumab has the potential to become the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options in ulcerative colitis, providing flexibility and simplicity for patients and physicians.1,4

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

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.1 Icotrokinra also showed sustained skin clearance and favourable safety profile, relative to placebo, in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study.2 Robust findings continue to demonstrate the potential of icotrokinra to transform the treatment paradigm for treating patients with moderate-to-severe plaque psoriasis.1,2