--- title: FDA Approves First Drug Meant to Treat Smallpox description: The Food and Drug Administration (FDA) on Friday approved TPOXX, or tecovirimat, the first drug specifically meant to treat smallpox. canonical: https://time.com/5338775/fda-small-pox-approval/ author: Jamie Ducharme article:opinion: false article:content_tier: free article:published_time: 2018-07-14T14:12:09.000Z article:modified_time: 2026-02-23T20:50:58.544Z article:section: Health og:title: FDA Approves First Drug Meant to Treat Smallpox og:description: Even though the disease was eradicated in 1980 og:url: https://time.com/5338775/fda-small-pox-approval/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt787127355ea3d019/6989355abc6cfcb5a73e673e/small-pox-virus.jpeg?branch=production&width=3840&quality=75&auto=webp&crop=16:9 og:image:width: 1200 og:image:height: 675 og:image:alt: Pox Virus og:type: article twitter:card: summary_large_image twitter:title: FDA Approves First Drug Meant to Treat Smallpox twitter:description: Even though the disease was eradicated in 1980 twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt787127355ea3d019/6989355abc6cfcb5a73e673e/small-pox-virus.jpeg?branch=production&width=3840&quality=75&auto=webp&crop=16:9 ---  # The FDA Approved an Anti-Bioterrorism Drug Meant to Treat Smallpox  by [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Jul 14, 2018 2:12 PM UTC  Variole Virus. Variole Virus.BSIP—UIG via Getty Images  by [Jamie Ducharme](https://time.com/author/jamie-ducharme/)  ## Jamie Ducharme Ducharme is a contributor to TIME. Jul 14, 2018 2:12 PM UTC The Food and Drug Administration (FDA) on Friday approved the first drug specifically designed to treat smallpox — despite the fact that the disease was officially eradicated in 1980. While the daily threat of smallpox, which is caused by the variola virus, is virtually non-existent, FDA Commissioner Scott Gottlieb said [in a statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm) that the drug, called TPOXX, or tecovirimat, could be a safeguard against bioterrorism. “To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” Gottlieb said. “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.” TPOXX’s efficacy was tested on animals with viruses closely resembling the variola virus under the FDA’s Animal Rule, which decrees that well-designed animal studies can be used in place of human trials when it would not be safe or ethical to test a drug on people. The drug’s safety was also tested on almost 360 human volunteers, who did not have smallpox. Tecovirimat, which is made by SIGA Technologies Inc., is the first in an upcoming string of approvals meant to reduce the risk of bioterrorism, Gottlieb said in the FDA’s announcement. “This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher,” Gottlieb said. “Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.” ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/5338775/fda-small-pox-approval/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/5338775/fda-small-pox-approval/"},"headline":"The FDA Approved an Anti-Bioterrorism Drug Meant to Treat Smallpox","datePublished":"2018-07-14T14:12:09.000Z","dateModified":"2026-02-23T20:50:58.544Z","description":"Even though the disease was eradicated in 1980","url":"https://time.com/5338775/fda-small-pox-approval/","keywords":["medicine","onetime","healthytime"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt787127355ea3d019/6989355abc6cfcb5a73e673e/small-pox-virus.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Jamie Ducharme","jobTitle":"Ducharme is a contributor to TIME.","url":"https://time.com/author/jamie-ducharme/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt787127355ea3d019/6989355abc6cfcb5a73e673e/small-pox-virus.jpeg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Pox Virus","caption":"Pox Virus","creditText":"BSIP—UIG via Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/medicine/","name":"medicine"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/5338775/fda-small-pox-approval/","name":"The FDA Approved an Anti-Bioterrorism Drug Meant to Treat Smallpox"}}]}] ```