FDA批准首个单剂流感药仿制药：巴洛沙韦片适用于5岁以上患者
美国食品药品监督管理局（Food and Drug Administration，FDA）6月17日批准首个 Xofluza（巴洛沙韦片，baloxavir marboxil）仿制药，这是首个单剂服用的流感治疗药物仿制版本，可用于治疗急性无并发症流感，也可用于流感暴露后预防，适用人群为 5 岁及以上患者。FDA 表示，这项批准赶在 2026 至 2027 年流感季之前落地。
获批的仿制巴洛沙韦片有两种用法：一是治疗 5 岁及以上、出现流感症状不超过 48 小时、且本身健康或属于流感并发症高风险人群的患者；二是供 5 岁及以上人群在接触流感患者后作暴露后预防。
FDA 药品评价与研究中心仿制药办公室主任 Iilun Murphy 表示：「今天的批准是流感治疗的一个重要里程碑。扩大患者用药可及性、提高用药便利程度是关键的公共卫生要务，尤其因为流感每年在美国造成数以百万计的病例。」
FDA 同时说明，已知对巴洛沙韦或其任何成分有过敏反应史的患者禁用该药；该药带有相关警示，包括 5 岁以下患者中治疗后耐药发生率上升。常见副作用包括腹泻、支气管炎、恶心、鼻窦炎与头痛，医疗人员应查阅完整处方信息了解全部安全与用药说明。
FDA 指出，美国开出的处方中十分之九为仿制药，增加仿制药供应有助于形成市场竞争、降低治疗费用并扩大医疗可及性。Xofluza 是 Genentech, Inc. 的注册商标，本次获批的仿制药申请方为 Norwich Pharmaceuticals, Inc.（据 FDA 官网新闻稿）
FDA Approves First Single-Dose Generic Flu Treatment: Baloxavir Marboxil Tablets for Patients 5 and Older
The U.S. Food and Drug Administration (FDA) on June 17 approved the first generic version of Xofluza (baloxavir marboxil tablets), the first single-dose treatment for acute uncomplicated influenza and for post-exposure prophylaxis in patients 5 years of age and older. The FDA said the approval came in time for the 2026-2027 flu season.
The generic baloxavir marboxil tablets may be used to treat acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications, and for post-exposure prophylaxis in patients 5 years of age and older following contact with an individual who has influenza.
"Today's approval marks a meaningful milestone for the treatment of influenza," said Iilun Murphy, M.D., Director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year."
The FDA said baloxavir marboxil tablets are contraindicated in patients with a known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients, and that the drug carries warnings including an increased incidence of treatment-emergent resistance in patients under 5 years of age. The most common side effects include diarrhea, bronchitis, nausea, sinusitis and headaches, and healthcare providers should review the full prescribing information.
The FDA noted that nine out of 10 prescriptions filled in the U.S. are for generic drugs, and that increasing their availability helps create competition, make treatment more affordable and increase access to healthcare. Xofluza is a registered trademark of Genentech, Inc.; the approved generic application was submitted by Norwich Pharmaceuticals, Inc. (According to the FDA news release on its official website)
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监督管理局（FDA）总部 White Oak 园区大楼。FDA 官方照片，公共领域。 / Photo: FDA headquarters building at the White Oak campus. U.S. Food and Drug Administration photo, public domain.
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