Innovative Medicine

Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring Landmark approval supports earlier intervention and disease interception of multiple myeloma for the first time

CAPLYTA®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications1,2 In pivotal trials, CAPLYTA® did not increase mean weight gain, metabolic changes, or reported sexual side effects1,2 In a six-month open-label extension safety study, safety profile was consistent with pivotal studies and 80% of MDD patients taking CAPLYTA® achieved response, with 65% of patients reaching remission from depression3 CAPLYTA® offers a new option for the 2 in 3 people who experience residual symptoms despite their current antidepressant treatment1,2,3

More than 60 abstracts spotlight leading portfolio and pipeline of innovative medicines in multiple myeloma, lymphoma, leukemia and other blood disorders

Expanded STELARA® indication seeks to treat children two years of age and older with moderately to severely active ulcerative colitis, based on Week 52 data from UNIFI Jr

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

Findings highlight opportunity for shared decision-making to improve treatment planning, with more than 90% of patients currently on injectables willing to switch to a new oral therapy with equivalent efficacy and a favorable safety profile Results show 50.5% of adult psoriasis patients eligible for systemic therapy and 47.5% of dermatology providers would prefer oral treatment over topicals or injectables

Clinical remission rates were over 85% for both TREMFYA® maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies TREMFYA® is the only IL-23 inhibitor to demonstrate durable endoscopic and clinical remission with a fully subcutaneous regimen in moderately to severely active Crohn’s disease

Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn’s disease

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