EMEA Search Results

Pulmonary hypertension

European Commission approves Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

With this approval, Yuvanci® is the only single tablet combination therapy for treatment for patients with PAH in Europe Johnson & Johnson’s comprehensive PAH portfolio now covers all three guideline-recommended foundational treatment pathways

Oncology

DARZALEX® (daratumumab) subcutaneous (SC) formulation-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned

Study demonstrates a minimal residual disease (MRD)-negativity rate of 60.9 percent and 43 percent reduction in the risk of progression or death 1 Phase 3 CEPHEUS study results presented in late-breaking oral presentation at the International Myeloma Society (IMS) Annual Meeting 1

Oncology

CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line

45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after three-year follow-up in landmark CARTITUDE-4 study1 Data featured in a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting1

Oncology

Novel combination of TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) suggest high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease

Data from the investigational Phase 1b RedirecTT-1 study demonstrate a safety profile consistent to talquetamab and teclistamab monotherapies1

Oncology

TALVEY®▼ (talquetamab) and DARZALEX® (daratumumab) subcutaneous (SC) formulation-based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma

Updated data show 100 percent overall response rate, with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody1 Safety profile, including infection rates, is similar to talquetamab and daratumumab SC monotherapies1

Oncology

DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma

Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death with daratumumab SC quadruplet regimen compared to current standard of care triplet regimen1

Oncology

New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)- unresponsive1

Oncology

RYBREVANT®▼ (amivantamab) plus chemotherapy show 49 percent overall response rate in metastatic colorectal cancer

Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease1 New results show potential of amivantamab beyond lung cancer1

Oncology

RYBREVANT®▼ (amivantamab) plus chemotherapy shows positive overall survival trend versus chemotherapy in patients with previously treated EGFR-mutated lung cancer

Post-progression outcomes showed significant and sustained improvement for amivantamab plus chemotherapy versus chemotherapy alone1

Immunology

Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis

Marks first EMA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 programme, the first registrational study results in the class demonstrating sustained disease control over 24 weeks in antibody-positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+

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