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Johnson & Johnson Receives Positive CHMP Opinion Recommending Full Approval for SIRTURO® (bedaquiline) for Treatment of Multidrug-Resistant Tuberculosis
CHMP recommends Conditional Marketing Authorisation be converted into standard Marketing Authorisation Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer significant improvement compared to other available therapies
Johnson & Johnson receives positive CHMP opinion for RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone1
CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1
Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting
Analysis of clinical and non-clinical studies supports the investigational treatment’s potential for rapid, deep and sustained immunoglobulin G (IgG) lowering
Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization
New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States
CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
Expanded indication for this one-time infusion will provide more patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with CARVYKTI® in 1-3 prior lines of therapy reduced the risk of disease progression or death by 59 percent compared to standard therapies
Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.24
Clinical and real-world evidence presentations highlight how the Company is transforming care for patients who are fighting some of the most common and devastating cardiovascular diseases
Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults
FNAIT is a rare disease that occurs when a pregnant person’s immune system attacks fetal platelets, resulting in the risk of internal bleeding, which can be life threatening to the fetus or newborn The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported to be in clinical development for the treatment of FNAIT
U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)
OPSYNVI® combines two proven treatments with established efficacy and safety profiles into one tablet to be taken once daily, offering an option that helps to support the implementation of clinical guideline recommendations for early use of combination therapy.1 The comprehensive PAH portfolio at Johnson & Johnson now includes treatments that address all three foundational and guideline-recommended pathways for this rare, progressive disease.2 Approval is based on the results from the pivotal Phase 3 A DUE study, which met its co-primary endpoints, demonstrating significant pulmonary hemodynamic improvement.1