MINISTONE-2研究在1-12歲之間的兒童流感患者中對(duì)照活性藥物（奧司他韋）評(píng)估了Xofluza的有效性與安全性。此外，全球III期MINISTONE-1研究也在評(píng)估Xofluza用于未滿1周歲兒童流感患者的安全性和療效。
羅氏首席醫(yī)學(xué)官和全球產(chǎn)品開發(fā)負(fù)責(zé)人Sandra Horning表示：
III期BLOCKSTONE臨床的陽性結(jié)果第一次證明了Xofluza可以降低流感在家庭成員之間的傳播幾率。預(yù)防流感在健康人群之間的傳播可以降低流感給整個(gè)社會(huì)帶來的負(fù)擔(dān)。
目前，Xofluza已經(jīng)在多個(gè)國家獲批，包括在日本用于治療兒童、青少年和成人的甲型和乙型流感；在美國用于治療年滿12周歲兒童的急性、無并發(fā)癥流感。此外，F(xiàn)DA接受了Xofluza作為單劑量口服治療手段，治療流感并發(fā)癥高風(fēng)險(xiǎn)人群的補(bǔ)充新藥申請(qǐng)（sNDA）。FDA預(yù)計(jì)將于11月4日前做出決定。
參考文獻(xiàn)：
[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
