食品药品监管局批准首个慢性乙肝反义寡核苷酸药Hibsago上市
食品药品监管局（FDA）10月20日批准 Hibsago（bepirovirsen，葛兰素史克 GSK）用于治疗慢性乙型肝炎，这是 FDA 批准的首个用于慢性乙肝的反义寡核苷酸药物。
获批适用人群为无肝硬化的成人患者，须已接受抗病毒治疗至少 6 个月、乙肝病毒 DNA 已受抑制，且乙肝表面抗原（HBsAg）不高于 3,000 IU/mL（以 FDA 授权检测为准）。FDA 同时授权罗氏 Elecsys HBsAg II quant II RxDx 作为伴随诊断。该药此前已获得快速通道、突破性疗法与优先审评资格。
用药方案为皮下注射、疗程至多 24 周，原有抗病毒药物须续用至末次注射后至少 24 周。在 B-Well 1 与 B-Well 2 两项三期试验中，24% 的受试者达到停用原抗病毒药的标准，安慰剂组为 0%；在停用全部治疗 24 周后，19% 的受试者仍保持病毒受控且 HBsAg 检测不到。FDA 药品评价与研究中心传染病办公室代理主任 Wendy Carter 就批准发表说明。
（据食品药品监管局批准公告）
FDA Approves Hibsago, the First Antisense Oligonucleotide Drug for Chronic Hepatitis B
The Food and Drug Administration on October 20 approved Hibsago (bepirovirsen, GSK) for the treatment of chronic hepatitis B, the first antisense oligonucleotide drug the FDA has approved for this indication.
The approval covers adults without cirrhosis who have been on antiviral therapy for at least six months, have suppressed HBV DNA, and have hepatitis B surface antigen (HBsAg) levels no higher than 3,000 IU/mL as measured by an FDA-authorized test. The FDA simultaneously authorized Roche's Elecsys HBsAg II quant II RxDx as a companion diagnostic. The drug had previously received Fast Track, Breakthrough Therapy, and Priority Review designations.
Hibsago is given by subcutaneous injection for up to 24 weeks, with prior antiviral therapy continued for at least 24 weeks after the last injection. In the phase 3 B-Well 1 and B-Well 2 trials, 24 percent of treated patients met criteria to stop their prior antiviral therapy, compared with 0 percent on placebo, and 19 percent maintained viral control with undetectable HBsAg 24 weeks after stopping all treatment. Wendy Carter, acting director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, commented on the approval.
(Based on the FDA approval announcement)
来源：食品药品监管局批准
发布：GSM·美国（发布链接）
图片来源：食品药品监管局大楼外观资料图。图：美国食品药品监管局，经维基共享资源，公共领域。 / File photo: an FDA building exterior. U.S. Food and Drug Administration, via Wikimedia Commons, public domain.
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