The development and approval of tecoviromat (TPOXX®), the first antiviral against smallpox

Details

• Alternative Title:
  Antiviral Res
• Personal Author:
  Merchlinsky, Michael ; Albright, Andrew ; Olson, Victoria ; Schiltz, Helen ; Merkeley, Tyler ; Hughes, Claiborne ; Petersen, Brett ; Challberg, Mark
• Description:
  The classification of smallpox by the U.S. Centers for Disease Control and Prevention (CDC) as a Category A Bioterrorism threat agent has resulted in the U.S. Government investing significant funds to develop and stockpile a suite of medical countermeasures to ameliorate the consequences of a smallpox epidemic. This stockpile includes both vaccines for prophylaxis and antivirals to treat symptomatic patients. In this manuscript, we describe the path to approval for the first therapeutic against smallpox, identified during its development as ST-246, now known as tecovirimat and TPOXX|, a small-molecule antiviral compound sponsored by SIGA Technologies to treat symptomatic smallpox. Because the disease is no longer endemic, the development and approval of TPOXX| was only possible under the U.S. Food and Drug and Administration Animal Rule (FDA 2002). In this article, we describe the combination of animal model studies and clinical trials that were used to satisfy the FDA requirements for the approval of TPOXX | under the Animal Rule.
• Subjects:
  Animals Antiviral Agents Benzamides Disease Models, Animal Drug Development Drug Evaluation, Preclinical Humans Isoindoles
• Source:
  Antiviral Res. 168:168-174
• Pubmed ID:
  31181284
• Pubmed Central ID:
  PMC6663070
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHS/United States
• Name as Subject:
  United States. Food and Drug Administration.
• Place as Subject:
  United States
• Volume:
  168
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:3421c81257f53879f34194391623e1e9a596aabeaff15feceb3594565f1737cd
• Download URL:
  https://stacks.cdc.gov/view/cdc/80233/cdc_80233_DS1.pdf
• File Type:
  [PDF - 83.54 KB ]