Noticias y eventos de Novartis AG (NVS)NVSNovartis AG

Novartis Reports Pivotal Results: Remibrutinib Significantly Reduces Relapse Rate

Novartis presented positive results from the pivotal Phase 3 REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis, showing that remibrutinib, a highly selective and efficacious oral Bruton's tyrosine kinase inhibitor, demonstrated superior relapse control and a clinically meaningful delay in disease progression versus teriflunomide with no liver safety signal. The study results were presented during a late-breaking session at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, and were published simultaneously in The Lancet. Remibrutinib reduced the annualized relapse rate versus teriflunomide, the primary endpoint of both trials, with statistically significant and clinically meaningful 35.2% and 31.2% relative reduction, translating to approximately one relapse every 13 years. Remibrutinib achieved a clinically meaningful delay in disability progression, reducing the risk of 6-month confirmed disability progression by 29.2%, with nominal significance, and a consistent positive trend of 20.5% reduction in 3-month confirmed disability progression. More than 92% of patients receiving remibrutinib remained free from disease progression over 24 months as assessed by 6mCDP. In addition to the efficacy findings, remibrutinib demonstrated no liver safety signal, including no Hy's Law cases, which have been reported in other late-stage BTK inhibitor programs, Novartis stated.

Novartis NATALEE Trial Shows Kisqali Combination Significantly Improves Survival

Novartis announced results from the six-year follow-up analysis of the Phase III NATALEE trial, reporting positive, clinically meaningful overall survival data with Kisqali plus endocrine therapy compared to ET alone. The study was in the broadest early breast cancer, eBC, population of patients with stage II and III HR+/HER2- early breast cancer at high risk of recurrence. Kisqali plus ET reduced the risk of death by nearly 20% compared to ET alone, with consistent overall survival benefit observed across all key subgroups. These late-breaking results will be presented at the European Society for Medical Oncology, ESMO, Annual Meeting 2026. Patients have been off Kisqali for a median of three years and have passed the five-year protocol-specified ET duration. The invasive disease-free survival, iDFS, benefit increased from 4.1% at five years to 5.3% at six years, underscoring the long-term value of dual inhibition, with benefit observed years after treatment completion. Fewer patients treated with Kisqali plus ET experienced metastatic recurrence compared to ET alone, and OS continued to increase over time, with the absolute difference increasing from 1.2% at five years to 2.1% at six years. Breast-cancer specific survival was supportive of OS benefit, showing an about 30% reduction in risk of breast cancer-specific compared to ET alone.

Novartis' Cosentyx Approved by EU for PMR Treatment

Novartis announced that the European Commission has approved Cosentyx for the treatment of adults with polymyalgia rheumatica, or PMR, who have had an inadequate response to glucocorticoids or who experience relapse during glucocorticoid taper. With this approval, Cosentyx becomes the first and only interleukin-17A inhibitor approved in Europe for adults with PMR, a common inflammatory rheumatic disease in adults aged over 50, the company stated.