FDA批准赛诺菲结核病药物Priftin联合异烟肼用于潜伏性结核感染治疗

FDA批准赛诺菲结核病药物Priftin联合异烟肼用于潜伏性结核感染治疗

                               
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发布日期：2014-12-03  来源：bidnessetc  

Prftin于1998年在美国上市，赛诺菲是极少数继续投资于结核病（TB）管理的药企之一，该公司自1950年一直致力于研发治疗诊断和预防结核病（TB）的方法。

   赛诺菲（Sanofi）近日宣布，经过优先审查之后，FDA已批准Priftin（rifapentine，利福喷丁）片剂联合异烟肼（isoniazid，INH）用于2岁及以上伴有发展为结核病（TB）高风险的潜伏性结核感染（latent tuberculosis infection，LTBI）的治疗。Priftin于1998年在美国上市，该药是一种抗分支杆菌药物，联合一种或多种抗结核药物用于活动性肺结核的治疗。

赛诺菲是极少数继续投资于结核病（TB）管理的药企之一。自1950年，该公司一直致力于研究和开发治疗、诊断和预防结核病（TB）的方法。

Priftin LTBI新适应症的获批，部分基于由美国疾病预防与控制中心(CDC)与结核病试验联盟（TBTC）联合开展的关键III期PREVENT TB研究的数据。该研究将12周每周一次Priftin+INH（3RPT/INH）方案作为直接观察疗法，与9个月自我管理每日一次INH（9INH）方案进行了比较。数据表明，3RPT/INH组（n=3074）有5例发展为结核病（TB），9INH组（n=3074）有10例发展为结核病（TB）。此外，3RPT/INH治疗组有81.2%的患者完成治疗，9INH组仅68.3%完成治疗。相关研究结果已于2011年发表于《新英格兰医学杂志》。

根据试验结果，CDC更新了潜伏性结核感染（LTBI）的治疗指南，推荐12周每周一次Priftin-INH方案作为9个月每日一次INH方案的等效替代方案。此外，在2014年10月，有关潜伏性结核感染（LTBI）管理的WHO指南，也已推荐将12周Priftin-INH方案作为一种治疗选择。

根据世界卫生组织（WHO），结核病（TB）是仅次于艾滋病（HIV/AIDS）由单一感染源导致的全球第二大杀手。在2013年，全球结核病患者总数达到900万例，死亡病例150万。目前，Priftin仅在美国上市，赛诺菲正积极努力使Priftin尽快在世界其他国家批。（生物谷Bioon.com）

Sanofi SA (SNY) Gets FDA Nod For Priftin Tablets To Treat Latent TB Infection
The FDA has approved Sanofi’s Priftin tablets, to be used in combination with isoniazid, for the treatment of latent tuberculosis infection

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Sanofi SA (ADR) (NYSE:SNY) announced before US markets opened for trading Tuesday that the US Food and Drug Administration (FDA) has approved its Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection.

The FDA, following a priority review, has approved Priftin, to be used in combination with isoniazid, for the new indication. The drug, first approved for sale in the US in 1998 to treat active pulmonary tuberculosis, can now be administered to patients over 2 years of age at high risk of developing the disease.

Sanofi said that Priftin must always be used in conjunction with isoniazid as a 12-week once-a-week treatment for latent tuberculosis infection. The only sign that a person is infected with the disease is that of a positive reaction to the TB skin or blood test. Without treatment, however, about 5-10% of those infected with latent tuberculosis infection will go on to develop TB at some point in their lives, with about 50% of these incidences occurring within the first two years of infection. The World Health Organization (WHO) estimates that 9 million people fell sick with TB in 2013, with 1.5 million people dying from the disease in the same year.

Paul Chew, Sanofi Global Chief Medical Officer, stated: “Today's approval highlights the importance of public-private partnerships to address unmet public health challenges, with Sanofi working with the U.S. Centers for Disease Control to study new opportunities to treat latent TB infection. The new approval for Priftin exemplifies the commitment to treating TB upheld by Sanofi for more than a half century.”