美国食品和药物管理局授予诺华公司药物ianalumab的突破性地位,用于治疗Sjögren病. FDA grants breakthrough status to Novartis drug ianalumab for Sjögren’s disease treatment.

美国食品和药物管理局已授予诺华公司药物ianalumab的突破性治疗指标,用于治疗Sjögren病,这是一种影响水分产生腺体的慢性自身免疫疾病. The FDA has granted Breakthrough Therapy designation to ianalumab, a Novartis drug, for treating Sjögren’s disease, a chronic autoimmune disorder affecting moisture-producing glands. 该药名是根据积极的第三阶段试验结果确定的,它承认该药有可能显著改善症状并解决严重未得到满足的医疗需求。 The designation, based on positive Phase III trial results, recognizes the drug’s potential to significantly improve symptoms and address a serious unmet medical need. Ianalumab是针对B细胞活动的一种单克隆抗体,在减少疾病负担方面显示出有意义的临床效益。 Ianalumab, a monoclonal antibody targeting B-cell activity, showed meaningful clinical benefits in reducing disease burden. Sjögren目前没有批准任何针对Sjögren的治疗方法,这影响到400万美国人。 No targeted therapies are currently approved for Sjögren’s, which affects up to 4 million Americans. Novartis计划从2026年初起在多个国家寻求监管批准。 Novartis plans to seek regulatory approval in multiple countries starting in early 2026.