Press Releases

Company prepares to support clinical trial in the United States

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

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

The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ 3 Electro-anatomical Mapping System, driving efficiency, reproducibility and accuracy1 Approval is supported by the admIRE study, where 85% peak primary effectiveness 12-month success and minimal-to-no fluoroscopy were achieved2,i

Highlights include the debut of the Solutions in Motion™ initiative aimed at bringing together advanced surgical techniques, innovative implants, and data-driven enabling technologies

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

Novel Intravascular Lithotripsy (IVL) catheter demonstrates ability to modify calcium safely, enabling treatment and crossing of tightly-stenosed lower limb lesions Technology has received U.S. FDA clearance for patients with peripheral arterial disease

DISRUPT BTK II, a global post-market study, finds favorable 30-day outcomes for peripheral IVL in the most challenging calcified lesions, including patients with CLTI

The OMNY-AF trial evaluates safety and efficacy of the investigational OMNYPULSE™ Platform, a novel catheter that combines a large ablation area with mapping capabilities