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U.S. Department of Health and Human Services

News Release

Friday, July 13, 2018
(202) 690-6343
​Twitter: @PHEgov

Statement by Rick Bright, PhD, Director of ASPR’s Biomedical Advanced Research and Development Authority on the recent FDA approval of TPOXX® as a treatment for smallpox

“The Food and Drug Administration’s (FDA) approval of TPOXX® (tecovirimat) as a treatment for smallpox marks a milestone for biosecurity and a triumph against one of the most deadly diseases in history. TPOXX®, produced by SIGA Technologies, is the first – and only—FDA-approved smallpox antiviral treatment.”

“The approval of TPOXX® serves as an exemplary model of government working collaboratively with its interagency partners and industry to meet a national biodefense need. The Biomedical Advanced Research and Development Authority (BARDA) supported the advanced research and development of TPOXX. The National Institutes of Health’s National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, and the U.S. Department of Defense United States Army Medical Research Institute of Infectious Disease and the Defense Threat Reduction Agency supported early stages of research. Together, these agencies worked with SIGA Technologies for more than 10 years to support the development of this product. Under Project BioShield, BARDA also supported the procurement of TPOXX for the Strategic National Stockpile.”

“TPOXX is the 38th FDA approval, licensure or clearance for a BARDA-supported product. Its approval takes us one step closer to meeting the U.S. biodefense goal to have two antiviral drugs and two vaccines FDA-approved for protecting Americans against the smallpox virus. To move us closer to that goal, BARDA is working toward the approval of a new smallpox vaccine as well as and another antiviral drug. In addition, BARDA is working toward the approval of an intravenous formulation of TPOXX® next year for patients who are too young or too sick to take oral medications.”

For more information about the FDA’s approval of TPOXX, access the press release.​​

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  • This page last reviewed: July 16, 2018