FDA快车道强生公司(Johnson & Johnson)的lupus药物Nipocalimab, 显示在减少疾病活动和类固醇使用方面有希望。 FDA fast-tracks Johnson & Johnson’s lupus drug nipocalimab, showing promise in reducing disease activity and steroid use.

美国食品及药物管理局(FDA)授予Johnson & Johnson调查疗法(nipocalimab)快速称号, 用于系统性的Lupus erethometatosus(SLE), 这是一种慢性自体免疫疾病, 影响美国约45万人。 The U.S. FDA has granted Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting an estimated 450,000 people in the U.S. 该称号确认大量医疗需求未得到满足,特别是对育龄妇女而言。 The designation recognizes the significant unmet medical need, especially for women of childbearing age. Nipocalimab以FcRn受体为目标,旨在减少有害的IgG抗体,同时保持免疫功能。 Nipocalimab在第二阶段b试验中显示出积极的成果,在主要终点实现了疾病活动改善和潜在的类固醇分解效应。 Nipocalimab, which targets the FcRn receptor to reduce harmful IgG antibodies while preserving immune function, showed positive results in a Phase 2b trial, meeting its primary endpoint with improved disease activity and potential steroid-sparing effects. Johnson & Johnson现正将病人送入GARDENIA第3阶段试验, 以进一步评估药物的安全性和功效。 Johnson & Johnson is now enrolling patients in a Phase 3 trial, GARDENIA, to further assess the drug’s safety and efficacy. 该疗法是第一个FcRn阻塞器,以展示在SLE的好处,还获得了针对其他自发性条件的快车道和孤儿药品指认。 The therapy is the first FcRn blocker to demonstrate benefits in SLE and has also received Fast Track and Orphan Drug designations for other autoimmune conditions.