Innovative Medicine

This submission is supported by data from the Phase 3 MARIPOSA-2 Study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of Oncology RYBREVANT® plus chemotherapy showed significant improvement in primary endpoint of progression-free survival, compared to chemotherapy alone, in patients with EGFR-mutated advanced non-small cell lung cancer following prior osimertinib therapy

People living with treatment-resistant active psoriatic arthritis reported meaningful improvements in pain, physical function and fatigue on TREMFYA through six monthsAdditional pooled data from three clinical trials support the established efficacy of TREMFYA in key psoriatic domains across those who were bio-naïve or TNFi-experienced

This first-ever clinical study of an FcRn inhibitor in RA showed nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity. Nipocalimab demonstrated improvements in primary and secondary endpoints and participants with higher baseline ACPAs had more than twice the placebo adjusted DAS28-CRP remission compared to the overall study population

STREAM Stage 2 study data submitted as part of Type II Variation to European Medicines Agency and supplemental New Drug Application to U.S. FDAData aim to support the full and traditional approval in the European Union and U.S., respectively

Data from the QUASAR induction study of adults with moderate to severely active ulcerative colitis show clinically meaningful results at Weeks 12 or 24 Additional data show symptomatic response as early as one week after the first induction dose, with symptomatic improvements increasing through Week 12

VISIBLE Cohort A Week 16 topline results achieve co-primary endpoints, demonstrating the well-established efficacy and safety profile of TREMFYA® across all skin tones In additional datasets, TREMFYA® demonstrated rapid and significant scalp psoriasis clearance and improved key health-related quality of life outcomes VISIBLE aims to generate an expansive longitudinal collection of PsO clinical images across skin tones and novel post-inflammatory pigmentation data to assist providers in helping patients better understand the diagnosis and treatment journey

The antiviral JNJ-1802 induced prophylactic antiviral activity against dengue in a human challenge model Dengue infects millions of people annually and could impact many more as climate change fuels outbreaks The antiviral, previously found to be safe and well-tolerated, is now in a community-based field study to establish efficacy in a real-world setting

Key efficacy endpoints of the long-term extension GALAXI study included clinical remission, patient-reported outcome remission, and endoscopic response

Data presentations reinforce potential for rapid, deep, and sustained efficacy with treatment and demonstrate how the unique immuno-selectivity of the compound may allow for greater targeting across a wide range of autoantibody-driven diseases