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Innovative Medicine
September 29, 2025
U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
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
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Innovative Medicine
September 22, 2025
Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR
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
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Innovative Medicine
September 19, 2025
TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen
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
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Innovative Medicine
September 19, 2025
Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG)
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
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Innovative Medicine
September 19, 2025
TECVAYLI® and DARZALEX FASPRO® treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma
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
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Innovative Medicine
September 17, 2025
Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis
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
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