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November 7, 2023

Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study

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

Innovative Medicine

November 7, 2023

Janssen Submits Phase 3 Study Data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO® (bedaquiline)

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

Innovative Medicine

October 23, 2023

New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement

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

Innovative Medicine

October 20, 2023

Janssen Announces TREMFYA® (guselkumab) Demonstrates Significant Skin Clearance in First-of-its-Kind Prospective, Large-Scale Study Dedicated to People of Color Living with Moderate to Severe Plaque Psoriasis

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

Global health equity

October 20, 2023

Janssen Announces Promising Antiviral Activity Against Dengue in a Phase 2a Human Challenge Model

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

Innovative Medicine

October 16, 2023

TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study

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

Innovative Medicine

October 16, 2023

Janssen to Highlight Latest Research from Nipocalimab Clinical Development Program to Address Unmet Need in Myasthenia Gravis at AANEM 2023 Meeting

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

Innovative Medicine

October 16, 2023

Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO

Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions New results for investigational TAR-200 and TAR-210 novel intravesical delivery system highlight potential for transformational outcomes in the treatment of bladder cancer

Innovative Medicine

October 9, 2023

Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress

30 presentations showcase breadth of data from Janssen’s Immunodermatology pipeline across five commercialized and investigational therapies

Innovative Medicine

October 6, 2023

Janssen Submits Application to the European Medicines Agency for RYBREVANT®▼ (amivantamab) in Combination with Chemotherapy for the First-Line Treatment of Adult Patients with Advanced Non-Small Cell Lung Cancer with Activating EGFR Exon 20 Insertion Mutations

Type II Extension of Indication Application is supported by data from PAPILLON, the first randomised Phase 3 study to read out in patients with NSCLC with EGFR exon 20 insertion mutations1

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