新闻通稿

上海, 03.07.2019

抗流感新药Xofluza公布最新两项研究结果,可大幅降低流感人际传播,治疗儿童流感表现良好耐受

7月3日,罗氏集团宣布其III期MINISTONE-2研究达到主要终点,结果表明儿童流感患者对XofluzaTM (baloxavir marboxil)的耐受性良好。研究还表明,Xofluza可以有效缩短发烧等儿童流感症状的持续时长。 

  • MINISTONE-2研究表明,通过口服混悬液制剂给药,Xofluza用于治疗1-12岁感染流感儿童,表现出良好耐受和治疗效力 。
  • 每年约有1/3的儿童患上流感,而且儿童的传染性比成人持续更久。所以,儿童流感治疗不但有助于减轻患者症状,而且有助于防控流感在广泛人群中传播。

 

罗氏首席医学官和全球产品开发负责人Sandra Horning表示:

儿童之所以亟需新的流感药物,是因为他们流感发病率高,出现呼吸问题和肺炎等并发症的可能性也高。这些流感并发症每年致使全球将近一百万未满五周岁的儿童住院,有时候甚至会致命。通过单次口服混悬液给药,Xofluza可以为儿童流感患者提供便利的治疗手段。我们期待与全球卫生机构分享这些数据。”

MINISTONE-2研究在1-12岁之间的儿童流感患者中对照活性药物(奥司他韦)评估了Xofluza的有效性与安全性。此外,全球III期MINISTONE-1研究也在评估Xofluza用于未满1周岁儿童流感患者的安全性和疗效。

  • Xofluza是首款也是目前唯一一款获批用于治疗流感的单剂量口服药物,也是FDA近20年来批准的具有新型作用机制的首款抗流感病毒药物。
  • Xofluza还是目前唯一一种表明对患有流感的健康人群(CAPSTONE-1)和流感并发症高风险人群(CAPSTONE-2)均有效的流感治疗手段。

此前, 6月4日公布的III期Blockstone临床研究显示,与安慰剂相比,单次口服一片Xofluza,流感在家庭成员之间的感染几率可大幅下降(Xofluza组感染流感几率1.9%,安慰剂组感染流感几率13.6%)。

 

罗氏首席医学官和全球产品开发负责人Sandra Horning表示:

“III期Blockstone临床的阳性结果第一次证明了Xofluza可以降低流感在家庭成员之间的传播几率。预防流感在健康人群之间的传播可以降低流感给整个社会带来的负担。”

目前,Xofluza已经在多个国家获批,包括在日本用于治疗儿童、青少年和成人的甲型和乙型流感;在美国用于治疗年满12周岁儿童的急性、无并发症流感。此外,FDA接受了Xofluza作为单剂量口服治疗手段,治疗流感并发症高风险人群的补充新药申请(sNDA)。FDA预计将于11月4日前做出决定。

 

 

 

参考文献:

[1] WHO 2019. Influenza. [Internet; cited 2019 June]. Available from: https://www.who.int/biologicals/vaccines/influenza/en/ 

[2] Centers for Disease Control and Prevention. How Flu Spreads. [Internet; cited 2019 June]. Available from: https://www.cdc.gov/flu/about/disease/spread.htm 

[3] Centers for Disease Control and Prevention. Children & Influenza (Flu). [Internet; cited 2019 June]. Available from: https://www.cdc.gov/flu/highrisk/children.htm 

[4] Nair H, et al. Global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis. Lancet. 2011; 378(9807):1917-30. 

[5] Sugaya, et al. Cap-dependent endonuclease inhibitor baloxavir marboxil for the treatment of influenza: phase 3, open-label study in Japanese otherwise healthy pediatric patients with seasonal influenza. IMRP 2018. Oral presentation.

[6] JapicCTI-163417. An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of S-033188 after Administration of a Single Dose to Otherwise Healthy Pediatric Patients Aged 6 Months to < 12 Years with Influenza. [Internet; cited 2019 June]. Available from: https://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-163417. Accessed October 2018.

[7] JapicCTI-173811. An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of S-033188 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza. [Internet; cited 2019 June]. Available from: https://rctportal.niph.go.jp/en/detail?trial_id=JapicCTI-173811. Accessed October 2018. 

[8] Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms. [Internet; cited 2019 June]. Available from: https://clinicaltrials.gov/ct2/show/NCT03653364?term=baloxavir&rank=1. Accessed June 2019. 

[9] Hayden FG, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. NEJM. 2018; 379(10):913-923.

[10] Ison M, et al. CAPSTONE-2 trial. Infectious Disease Week; 2018 Oct 3-7; San Francisco. CA, USA. Abstract #LB16. Available from: https://idsa.confex.com/idsa/2018/webprogram/Paper74204.html. 

[11] Roche Investor Update. Phase III study showed Xofluza (baloxavir marboxil) is effective at preventing influenza infection. [Internet; cited 2019 June]. Available from: https://www.roche.com/investors/updates/inv-update-2019-06-04b.htm