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Johnson & Johnson’s Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer’s Disease
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
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) shows statistically significant and clinically meaningful improvement in overall survival versus osimertinib
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
European Commission approves RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell 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
Johnson & Johnson to license novel oral assets, further strengthening commitment to atopic dermatitis
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
Warm autoimmune hemolytic anemia (wAIHA) research presented by Johnson & Johnson highlights profound disease burden and unmet need for targeted treatment options
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
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens demonstrate improved rates of minimal residual disease (MRD) negativity and progression-free survival in patients with newly diagnosed multiple myeloma
New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with DARZALEX FASPRO® were progression free at 4.5 years Subgroup analysis from Phase 3 AURIGA study show higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma
TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma
First and only subcutaneous anti-CD38 therapy demonstrating potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study
Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab)
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis