Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox

Kirk M Chan-Tack; Patrick R Harrington; Su-Young Choi; Laine Myers; Julian O'Rear; Shirley Seo; David McMillan; Hanan Ghantous; Debra Birnkrant; Adam I Sherwat

doi:10.1016/S1473-3099(18)30788-6

Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox

Lancet Infect Dis. 2019 Jun;19(6):e221-e224. doi: 10.1016/S1473-3099(18)30788-6. Epub 2019 Mar 7.

Affiliations

¹ Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: kirk.chan-tack@fda.hhs.gov.
² Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
³ Office of Translational Sciences, Office of Clinical Pharmacology, Division of Clinical Pharmacology IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

PMID: 30853252
DOI: 10.1016/S1473-3099(18)30788-6

Abstract

The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Antiviral Agents / therapeutic use*
Benzamides / therapeutic use*
Disease Eradication
Drug Approval*
Humans
Isoindoles / therapeutic use*
Smallpox / drug therapy*
Treatment Outcome
United States
United States Food and Drug Administration

Substances

Antiviral Agents
Benzamides
Isoindoles