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。
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