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SIGA’s Smallpox Drug Tecovirimat Looks Primed For Smooth US FDA Panel Review

 
• By Sue Sutter

Although not tested in smallpox animal models, tecovirimat demonstrated efficacy in surrogate orthopoxvirus disease models in non-human primates and rabbits, FDA says; SIGA seeks approval under the 'Animal Rule' for a broad population of adult and pediatric patients, but agency notes drug's safety has not been clinically tested in children and other vulnerable populations.

Variola virus, a virus from Orthopoxviridae family that causes smallpox, highly contagious disease eradicated by vaccination, 3D illustration
A lack of reliable variola virus animal models required SIGA to test tecovirimat in models using surrogate orthopoxviruses.

Siga Technologies Inc.’s Tpoxx (tecovirimat) appears primed for smooth passage through the US FDA’s Antimicrobial Drugs Advisory Committee given the agency’s conclusion that the smallpox disease treatment has satisfied all the tenets of the “Animal Rule.”

At a May 1 meeting, the advisory committee will be asked to vote on whether, based on the available data, tecovirimat’s risk-benefit

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