本文選題：慢性丙型肝炎 + FDA�。� 參考：《中國(guó)感染與化療雜志》2015年01期

【摘要】：正2013年10月24日訊楊森有限責(zé)任公司研究與開發(fā)部今天宣布美國(guó)食品藥品監(jiān)督管理局(FDA)抗病毒藥顧問(wèn)委員會(huì)根據(jù)臨床試驗(yàn)結(jié)果,一致投票(19∶0)建議批準(zhǔn)在代償期肝病(包括肝硬化)的成人患者中,蛋白酶抑制劑simeprevir(每粒150 mg膠囊每天1次)與聚乙二醇干擾素和利巴韋林聯(lián)合治療基因1型慢性丙型肝炎。simeprevir的批準(zhǔn)主要根據(jù)3個(gè)關(guān)鍵性Ⅲ期臨床試驗(yàn)的
[Abstract]:October 24, 2013-the Research and Development Department of Yang Sen Co., Ltd. announced today that the Food and Drug Administration (FDA) Advisory Committee on Antiviral Poisons, based on the results of clinical trials, A unanimous vote of 19: 0 recommended approval in adult patients with compensatory liver disease, including cirrhosis, The approval of protease inhibitor simeprevirl (150mg capsule per day) combined with pegylated interferon and ribavirin for the treatment of chronic hepatitis C type 1 is based on three critical phase 鈪，

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