J&J's Tuberculosis Drug Gets FDA Nod for Adolescent Patients

美国FDA加速批准强生公司Sirturo用于联合治疗青少年多耐药性肺结核

2019-08-13 15:05:00 Zacks

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Johnson & Johnson JNJ announced that the FDA has granted accelerated approval to its antimycobacterial tablets, Sirturo as a combination therapy to treat adolescents with pulmonary multidrug-resistant tuberculosis . Sirturo is already marketed in combination with a background regimen for treating MDR-TB in adults. Continued approval for the adolescent indication will be based on verification of data from confirmatory studies. A similar application is also under review in the EU. The approval for Sirturo in adolescents patient group (12 to less than 18 years of age and weighing at least 30 kg) was based on a cohort of a J&J phase II pediatric pharmacokinetic and safety study, C211. The other cohorts of the study are evaluating Sirturo in pediatric patients in different age groups. For the adolescent patient group, the formulation (100 mg tablet) and the dosing recommendation are the same as those approved for adults.  Tuberculosis is a deadly infectious disease, which claimed the lives of 230,000 children in 2017. Though it is more common in adult patients, all age groups are at risk. J&J’s stock has risen 2.3% this year so far against a decrease of 1.3% recorded by the industry.
强生 JNJ 公司宣布, FDA 已批准加速批准其抗菌药片 Sirturo 作为治疗青少年肺多药耐结核的联合疗法。 Sirturo 已经与治疗成人耐多养生法结核病的背景方案联合上市。持续批准的青少年适应症将基于验证数据的确认研究。欧盟也在审查类似的申请。 批准 Sirturo 在青少年患者组(12至18岁以下,体重至少30公斤)是基于一组 J & J 二期儿科药代动力学和安全研究, C211。另一组研究人员正在评估不同年龄组的儿童患者的 Sirturo 。对于青少年患者组,制剂(100mg 片剂)和剂量推荐与成人批准的相同。 结核病是一种致命的传染病,2017年夺去了23万儿童的生命。虽然这在成人患者中比较常见,但所有年龄组都处于危险之中。 今年迄今为止,强生(J&J)的股价已上涨2.3%,而该行业的股价则下跌了1.3%。

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