Mon. Sep 8th, 2025

Novartis has announced that its investigational therapy, ianalumab, has demonstrated potential in Phase 3 clinical trials for the treatment of Sjögren’s syndrome, a chronic autoimmune disorder characterized by inflammation of the exocrine glands, particularly the salivary and lacrimal glands. The trials, which were conducted globally, enrolled patients with active Sjögren’s syndrome and evaluated the efficacy and safety of ianalumab compared to placebo. According to the results, ianalumab showed significant improvements in symptoms and quality of life for patients with Sjögren’s syndrome. The treatment was also found to be generally well-tolerated, with a safety profile consistent with previous studies. Sjögren’s syndrome is a debilitating condition that affects millions of people worldwide, causing symptoms such as dry mouth, dry eyes, and joint pain. Current treatments for the condition are limited, and there is a significant need for effective and targeted therapies. Ianalumab, a monoclonal antibody, works by targeting the CD40 ligand, a protein involved in the activation of immune cells. By blocking this protein, ianalumab aims to reduce inflammation and modulate the immune response. The Phase 3 trials were designed to evaluate the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome, with a focus on symptoms such as dry mouth and dry eyes. The results of the trials are expected to be presented at upcoming medical conferences and published in peer-reviewed journals. Novartis plans to submit the data to regulatory authorities for review and potential approval. If approved, ianalumab could become a valuable treatment option for patients with Sjögren’s syndrome, offering a new approach to managing the condition. The development of ianalumab is part of Novartis’ ongoing commitment to advancing the treatment of autoimmune diseases. The company has a strong pipeline of investigational therapies in development, including several targeted treatments for autoimmune conditions. Ianalumab has also been granted orphan drug designation by the US FDA and the European Medicines Agency, recognizing its potential to address a significant unmet medical need. The designation provides incentives for the development and commercialization of ianalumab, including tax credits and market exclusivity. Novartis is a global leader in the development of innovative therapies, with a focus on addressing unmet medical needs in areas such as oncology, immunology, and neuroscience. The company has a strong track record of bringing new treatments to market, and its pipeline includes several promising therapies in development. In addition to ianalumab, Novartis is also developing other treatments for autoimmune diseases, including therapies for conditions such as rheumatoid arthritis and lupus. The company’s commitment to advancing the treatment of autoimmune diseases is driven by its mission to improve the lives of patients and families affected by these conditions. With the potential approval of ianalumab, Novartis could make a significant impact on the lives of patients with Sjögren’s syndrome, offering a new treatment option that could improve symptoms and quality of life. The development of ianalumab is a testament to the power of innovation and collaboration in the pursuit of medical breakthroughs. As the treatment landscape for autoimmune diseases continues to evolve, Novartis is well-positioned to play a leading role in shaping the future of care for patients with these conditions.

Source