FDA受理首款口服过敏急救膜片Anaphylm重新申报 2027年3月16日前定夺
总部位于新泽西州沃伦的制药公司Aquestive Therapeutics于10月15日宣布，美国食品药品监督管理局（FDA）已确认受理其Anaphylm（dibutepinephrine）舌下膜片的新药申请重新申报，认定申报完整，并定下2027年3月16日的审评目标日期（PDUFA）。该药用于治疗包括过敏性休克在内的I型过敏反应；若获批准，将成为首款也是唯一一款口服过敏急救药物。
Anaphylm是一张邮票大小的膜片，重量不足一盎司，入口即溶，无需用水或吞咽；包装比一张信用卡更薄更小，可放进手机壳或钱包。肾上腺素是严重过敏反应的标准急救用药，目前患者主要依靠自动注射笔给药。
这条申报之路走过一轮波折：FDA曾于2026年1月30日发出完整回应函，要求补充材料；公司今年8月公布了人体工学与药代动力学研究的积极顶线结果，并于9月16日重新提交申请，此次被FDA按「二类回复」受理。公司总裁兼首席执行官丹尼尔·巴伯表示，受理与目标日期的确定为Anaphylm「提供了一条清晰的前进道路」，公司正同步推进商业化准备，并计划于2026年第四季度向加拿大卫生部提交新药申报。
（据Aquestive Therapeutics 10月15日经GlobeNewswire发布的公司公告）
FDA Accepts Resubmission of Anaphylm, a Sublingual Epinephrine Film, With a March 16, 2027 Decision Date
Aquestive Therapeutics of Warren, New Jersey, announced on October 15 that the U.S. Food and Drug Administration has accepted its resubmission of the New Drug Application for Anaphylm (dibutepinephrine) sublingual film as complete, assigning a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027. The film is intended to treat Type I allergic reactions, including anaphylaxis; if approved, it would be the first and only oral rescue medication for severe allergic reactions.
Anaphylm is a film about the size of a postage stamp, weighing less than an ounce. It begins to dissolve on contact, requiring no water or swallowing, and its packaging is thinner and smaller than a credit card, designed to be carried in a phone case or wallet. Epinephrine is the standard emergency treatment for severe allergic reactions and is currently delivered mainly by auto-injector.
The path to this point has had one setback: the FDA issued a Complete Response Letter on January 30, 2026. Aquestive announced positive topline results from human factors and pharmacokinetic studies in August and resubmitted the application on September 16; the FDA classified the resubmission as a Class 2 response. President and CEO Daniel Barber said the acceptance and goal date give Anaphylm "a clear path forward," and that the company is advancing commercial preparations while remaining on track to file a New Drug Submission with Health Canada in the fourth quarter of 2026.
(Source: Aquestive Therapeutics)
来源：Aquestive Therapeutics
发布：GSM·美国（发布链接）
图片来源：美国食品药品监督管理局（FDA）位于马里兰州银泉市白橡树园区的办公楼。图片来源：Wikimedia Commons，美国FDA官方照片，公共领域
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