Novartis AG said its investigational monoclonal antibody ianalumab met the primary endpoint in both of its global Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, in adults with active Sjögren’s disease. The drug produced a statistically significant reduction in systemic disease activity, measured by the EULAR Sjögren’s Syndrome Disease Activity Index, compared with placebo. The twin studies, which together enrolled about 780 patients, also indicated a favourable safety profile. Novartis plans to present full results at an upcoming medical congress and submit the data to regulators worldwide. The antibody, which has US FDA Fast Track status, could become the first targeted therapy approved for the chronic autoimmune condition. Ianalumab originated from Novartis’s €2.7 billion acquisition of Germany’s MorphoSys in 2024 and is being tested in several other B-cell-driven disorders, including systemic lupus erythematosus. News of the successful trials lifted Novartis shares as much as 2.2% in early Zurich trading, extending the stock’s year-to-date gain to about 8%.
Novartis dijo que un medicamento experimental ayudó a pacientes con una enfermedad autoinmune en estudios de última etapa, ofreciendo un impulso a los esfuerzos: https://t.co/Jp8rRWw6dX
Novartis' MorphoSys-sourced antibody aces twin pivotal trials in Sjögren's $NVS https://t.co/zImgixtoCC
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