Innovative Medicine
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy1
Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren’s disease study
Adults with moderately-to-severely active Sjögren’s disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease based on results from the Phase 2 DAHLIAS study
Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson’s nipocalimab has received this designation
Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024
New data for investigational nipocalimab in Sjögren’s Disease (SjD) and new research on the impact of TREMFYA® (guselkumab) in psoriatic arthritis (PsA) will be highlighted across three oral sessions and a plenary session Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key efficacy endpoints at Week 24 compared with placebo, presented in a plenary session Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA®, presented as an oral presentation
European Commission Approves Expanded Use of HIV-1 Therapy EDURANT® (rilpivirine) in Younger Pediatric Patients
Approval provides a new treatment option for some of the youngest people living with HIV-1 in the European Union
TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease
A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn’s disease (CD), pending FDA approval
New SPECTREM study findings reveal TREMFYA® (guselkumab) effectively clears overlooked and undertreated plaque psoriasis
First-of-its-kind Phase 3b study shows TREMFYA® achieved statistical significance across all primary and secondary endpoints in low body surface area psoriasis with special site involvement Johnson & Johnson launches library of clinical images from Phase 3b VISIBLE study to enhance clinical decision making for people across all skin tones living with moderate to severe plaque psoriasis
Johnson & Johnson highlights innovative neuropsychiatry portfolio and pipeline at Psych Congress
• New five-year data reinforce long-term safety and efficacy of SPRAVATO® (esketamine) in patients with inadequate response to two or more oral antidepressants (treatment-resistant depression) • 23 abstracts highlight data from Company’s robust portfolio and pipeline, including clinical insights on major depressive disorder and the significant burden of anhedonia and insomnia symptoms • Large real-world analysis highlights the link between reducing relapse and improving survival in schizophrenia