跟进：FDA紧急授权Bravecto治疗犬只新世界螺旋蝇感染：对螺旋蝇紧急授权累计达16项

美国食品药品监管局（FDA）11月3日宣布，对默克动物保健（Merck Animal Health）旗下 Intervet 公司的 Bravecto 片剂发出紧急使用授权（EUA），用于治疗犬与幼犬的新世界螺旋蝇（New World screwworm）感染。FDA 表示，依据现有科学证据，有理由相信该药可能有效治疗螺旋蝇感染，且按授权方式使用时，其潜在收益大于风险。

Bravecto 的活性成分是 fluralaner，此前已获准用于犬只的跳蚤与蜱虫防治。FDA 提示，fluralaner 所属的异噁唑啉类驱虫药与肌肉震颤、共济失调、癫痫等神经系统不良反应有关。此次获授权的药片仅凭执业兽医处方供应。FDA 同时表示，美国大多数犬只面临的风险仍然较低，已确认病例集中在受限的地理区域内。

新世界螺旋蝇学名 Cochliomyia hominivorax，其幼虫会钻入温血动物的开放伤口与黏膜、啃食活组织，可感染牲畜、宠物与野生动物，罕见情况下也感染人，严重时可致动物死亡。2025年8月18日，美国卫生与公众服务部部长宣布该寄生虫构成潜在公共卫生紧急事态，FDA 据此得以通过紧急授权通道加快供应相关动物用药。截至11月3日，FDA 已对螺旋蝇药物发出16项紧急使用授权，并给出3项有条件批准，其兽医中心正与农业部（USDA）、环境保护署（EPA）及各州动物卫生官员协同应对。

本站此前持续报道这轮螺旋蝇北上疫情：农业部主导全国应对并在德克萨斯州 Edinburg 投入7.5亿美元建设不育蝇工厂；10月下旬，亚利桑那州确认全州首例病例、一只犬只伤口发现蝇蛆，新墨西哥州与德克萨斯州的疫区划分随后多次调整。此次针对犬只的常用驱虫药获紧急授权，为宠物兽医一线增加了现成的治疗选项。

关联：跟进：亚利桑那州首例新世界螺旋蝇 Cochise County一只狗确诊 农业部设20公里感染区

（来源：美国食品药品监管局）

Follow-Up: FDA Issues Emergency Use Authorization for Bravecto to Treat New World Screwworm in Dogs and Puppies

The U.S. Food and Drug Administration (FDA) announced on November 3 that it has issued an emergency use authorization (EUA) for Bravecto tablets, made by Intervet, a unit of Merck Animal Health, to treat New World screwworm infestations in dogs and puppies. The FDA said that, based on the available scientific evidence, it is reasonable to believe the drug may be effective in treating screwworm infestations and that its potential benefits outweigh its risks when used as authorized.

Bravecto's active ingredient is fluralaner, which was already approved for flea- and tick-related uses in dogs and puppies. The FDA noted that fluralaner belongs to the isoxazoline class of antiparasitic medicines, which has been associated with neurologic adverse reactions including muscle tremors, loss of coordination and seizures. The authorized tablets are available only by prescription through a licensed veterinarian. The FDA also said most dogs in the United States remain at low risk, as confirmed cases are limited to a restricted geographic area.

The New World screwworm, Cochliomyia hominivorax, is a parasitic fly whose larvae burrow into the open wounds and mucous membranes of warm-blooded animals and feed on living tissue. It can infest livestock, pets and wildlife, occasionally birds, and in rare cases people, and the damage is often deadly to the animal. On August 18, 2025, the Secretary of Health and Human Services declared that the screwworm presents a significant potential for a public health emergency, allowing the FDA to use the emergency authorization pathway for animal drugs. As of November 3, the FDA has issued 16 emergency use authorizations and three conditional approvals for screwworm drugs, and its Center for Veterinary Medicine is working with the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and state animal health officials on the response.

GSM has been following the screwworm's northward spread: the USDA is spearheading the national response and is building a $750 million sterile-fly facility in Edinburg, Texas; in late October, Arizona confirmed its first case, in a dog whose wound was found to carry larvae, and quarantine zones in New Mexico and Texas have been adjusted repeatedly since. The authorization of a widely used dog antiparasitic gives front-line veterinarians a ready treatment option for pets.

Related: Follow-Up: First New World Screwworm Detection in Arizona Confirmed in a Cochise County Dog, USDA Sets 20-km Infested Zone

(Source: U.S. Food and Drug Administration)

来源：美国食品药品监管局

发布：GSM·美国（发布链接）

图片来源：图：美国食品药品监管局（FDA）位于马里兰州 Silver Spring 的 White Oak 园区总部大楼（GSM 四级固定图库）。 / Photo: U.S. Food and Drug Administration headquarters at the White Oak campus in Silver Spring, Maryland (GSM fixed asset library).

GSM Global · 本篇英文版 English edition of this story

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