Innovative Medicine

Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1

Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1

Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson’s robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potential in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation

Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4

Building on decades of the Company’s Alzheimer’s research, two differentiated investigational therapies aim to slow pathological tau in distinct populations Fast Track designations reinforce J&J’s commitment to Alzheimer’s disease development and the potential of its precision approach

Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer

This multitargeted, chemotherapy-free combination demonstrated superiority over osimertinib monotherapy for the first-line treatment of patients with EGFR-mutated NSCLC1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced the risk of disease progression or death by 30 percent versus osimertinib monotherapy1

The Company is licensing a STAT6 program from Kaken Pharmaceutical that targets a clinically relevant pathway in atopic dermatitis as well as other autoimmune and allergic diseases The agreement bolsters Johnson & Johnson’s commitment to addressing disease-relevant pathways across patient types through novel mechanisms and modalities to transform the treatment of atopic dermatitis as well as other autoimmune and allergic diseases

Abstracts presented at ASH 2024 provide insight into the patient experience given the unpredictable nature of wAIHA, a rare autoantibody disease, and the uncertainty of current treatment approaches used to manage the condition There are no FDA-approved therapies indicated for wAIHA, and patients living with this condition need targeted treatment options with a proven safety and efficacy profile Johnson & Johnson is evaluating nipocalimab for the potential treatment of wAIHA in the Phase 2/3 ENERGY study, which is expected to read out in 2025