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Animals Rule: SIGA’s Smallpox Drug Tecovirimat Sails Through US FDA Panel

 
• By Sue Sutter

Antiviral wins unanimous endorsement on strength of efficacy data in two animal models and absence of major safety concerns in humans. FDA's advisors also see potential utility in other orthopoxviruses, particularly naturally occurring monkeypox outbreaks in Africa.

FDA Advisory Committee Feature image

 A US FDA advisory committee unanimously endorsed the approval of Siga Technologies Inc.’s Tpoxx (tecovirimat) as a treatment for smallpox May 1 but also saw opportunities for the antiviral’s study and use in other orthopoxviruses.

The Antimicrobial Drugs Advisory Committee voted 17-0 that the risk-benefit profile of tecovirimat supports its use for treatment of smallpox

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