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CHMP建议有条件批准强生结核病药物Sirturo

  1. 强生
  2. 结核杆菌
  3. 耐多药结核病
  4. Sirturo
  5. bedaquiline

来源:生物谷 2013-12-25 08:15

欧盟CHMP建议有条件批准强生结核病药物Sirturo,用于耐多药结核病的治疗。该药此前已获FDA加速批准,是近40年来FDA首次批准的抗结核药物。

2013年12月25日讯 /生物谷BIOON/ --上周五,强生(JNJ)结核病药物Sirturo(bedaquiline,双芳基喹啉类抗结核药)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议授予Sirturo有条件上市许可(conditional marketing authorisation),将该药作为组合疗法的一部分,用于因耐药性或耐受性使得一种有效治疗方案不能用于其临床治疗的耐多药结核病(multidrug-resistant tuberculosis,MDR-TB)成人患者的治疗。

此前,Sirturo已被指定为孤儿药地位。

去年12月,FDA通过加速审批程序批准了Sirturo,这是近四十年来FDA首次批准的抗结核药物,在无其它替代药物可用时作为成人多重耐药的结核(TB)联合治疗的组成部分。

结核病(tuberculosis)是由结核杆菌(Mycobacterium tuberculosis)引发的一种传染性疾病,主要影响肺部。在欧盟,结核病是一种罕见病,据2011年预计数据,结核病在欧盟的发病率约为万分之2.3。耐多药结核病是指至少对异烟肼( isoniazid)和利福平(rifampicin)耐药的结核病,这2种药物是用于结核病标准治疗中的2种主要的抗结核药物。据估计,在全球范围内,每年发生约45万例耐多药结核病病例,相当于全球每年结核病的5%。

近年来,由于缺乏新的治疗选择,耐药性结核病所导致的公共健康问题迅速增加。耐多药结核病与高的死亡率相关,已构成了严重的公共健康威胁,因为感染了耐药菌株的患者无法获得充分的治疗,并有可能传播感染。

Sirturo则为那些没有其他治疗选择的患者带来了希望。但是,该药也有一些严重的风险,医生应确保合理应用该药物,只适用于对其他抗结核治疗无效的患者。

Sirturo是一类新的抗结核杆菌药物的首个代表。CHMP认为,Sirturo可能有助于应对多耐药结核病在新治疗选择方面远未满足的医疗需求。因此,CHMP建议授予Sirturo有条件上市许可,尽管强生所提供的数据表明,Sirturo的临床利益大于其风险,但这些数据尚不全面。因此,应该就Sirturo的使用开展更多的研究。(生物谷Bioon.com)

英文原文:European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Tuberculosis is an infection caused by Mycobacterium tuberculosis that primarily affects the lungs. In the European Union, tuberculosis is an orphan indication and was estimated in 2011 to occur in 2.3 out of 10,000 people. Multidrug-resistant tuberculosis is defined as tuberculosis that is resistant to at least isoniazid and rifampicin, which are two major anti-tuberculosis medicines used in standard treatment. Approximately 450,000 cases of multidrug-resistant tuberculosis occur globally every year, which corresponds to approximately 5% of the world's annual burden of tuberculosis.

In recent years, the burden of tuberculosis resistant to first-line therapy has increased rapidly in the absence of new treatment options. Multidrug-resistant tuberculosis is associated with a high mortality rate and poses a significant public-health threat as individuals infected with drug-resistant strains are unable to receive adequate treatment and can potentially spread their infection.

Sirturo is the first representative of a new class of medicines against mycobacteria. The Committee considered that Sirturo could contribute to responding to the high unmet medical need for new treatment options for pulmonary multidrug-resistant tuberculosis. It recommended granting conditional marketing authorisation because, although the data supplied by the applicant show that the medicine's benefits outweigh its risks, the data are not yet comprehensive. Therefore, additional studies on the use of Sirturo should be conducted.

Sirturo is the third positive opinion recently granted by the CHMP for a medicine to be used in the treatment of multidrug-resistant tuberculosis, after the November 2013 recommendations for Deltyba (also for a conditional approval) and Para-aminosalicylic acid Lucane. This highlights the Agency's ongoing efforts to tackle the growing public-health challenge of antibacterial resistance.

The CHMP opinion on Sirturo will now be sent to the European Commission for the adoption of a marketing-authorisation decision.

Notes

The applicant for Sirturo is Janssen-Cilag International N.V
Sirturo has been designated as an orphan medicinal product.
Conditional approval allows the marketing authorisation of medicines that target areas of unmet medical need before comprehensive data sets are available, to speed up patient access to much needed new medicines.

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