Innovative Medicine

Approval expands SIMPONI® indication to treat children weighing at least 15 kg with moderately to severely active ulcerative colitis SIMPONI® is the only approved treatment to offer a monthly maintenance dose for this patient population

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis

Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis

TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16

Seltorexant, in combination with an oral antidepressant, demonstrated a numerically greater response rate at week 26 with a more favorable safety and tolerability profile compared to adjunctive quetiapine XR Patients treated with adjunctive seltorexant also saw notably less weight gain, and somnolence rates were four times lower than those in patients treated with adjunctive quetiapine XR

TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn’s disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab) in Crohn’s disease, based on the confidence in the clinical profile

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