Johnson & Johnson (JNJ), a global health care company, has received full approval from the US FDA and the European Commission for Sirturo (bedaquiline), a treatment specifically designed for pulmonary tuberculosis resistant to rifampicin and isoniazid.Sirturo had previously received accelerated approval from the US FDA in December 2012 and conditional approval from the European Medicines Agency (EMA) in March 2014, based on positive Phase 2 study data.The recent traditional approval by the FDA allows Sirturo to be used as a part of combination therapy in both adults and pediatric patients with pulmonary tuberculosis (TB) caused by mycobacterium tuberculosis strains resistant to rifampicin and isoniazid.This approval marks a significant milestone, as it removes previous label restrictions.The decision to grant full approval was based on the Phase 3 STREAM Stage 2 study- a large-scale, randomized, multi-country clinical trial..

全球医疗保健公司强生公司（JNJ）已获得美国FDA和欧盟委员会对Sirturo（bedaquiline）的全面批准，Sirturo是一种专门针对耐利福平和异烟肼的肺结核的治疗方法。Sirturo之前曾于2012年12月获得美国FDA的加速批准，并于2014年3月获得欧洲药品管理局（EMA）的有条件批准，这是基于积极的2期研究数据。FDA最近的传统批准允许Sirturo作为成人和儿童肺结核（TB）患者联合治疗的一部分，该患者由耐利福平和异烟肼的结核分枝杆菌菌株引起。这一批准标志着一个重要的里程碑，因为它删除了以前的标签限制。授予完全批准的决定是基于第三阶段STREAM第二阶段研究-一项大规模，随机，多国临床试验。。

The study evaluated the efficacy and safety of an all-oral bedaquiline-containig regimen for multidrug-resistant tuberculosis (MDR-TB). Compared to a 9-month injectable-based regimen, the bedaquiline-containig regimen showed significant improvement in treatment outcomes.Sirturo is now a core component of WHO-recommended treatment guidelines for MDR-TB with over 845,000 courses shipped to 160 countries.The company continues to invest in the healthcare professional training, resistance testing, and community-centered initiatives to ensure accessibility and effectiveness of the treatment for TB patients globally.JNJ has traded in a range of $143.13 to $175.97 in the last 1 year.

该研究评估了全口服含贝达喹啉方案治疗耐多药结核病（MDR-TB）的疗效和安全性。与9个月的基于注射的方案相比，含贝达喹啉的方案在治疗结果方面显示出显着改善。Sirturo现在是世卫组织推荐的耐多药结核病治疗指南的核心组成部分，向160个国家运送了845000多个疗程。该公司继续投资于医疗保健专业培训、耐药性检测和以社区为中心的举措，以确保全球结核病患者的治疗可及性和有效性。JNJ在过去一年的交易价格在143.13美元至175.97美元之间。