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

Executive Summary

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.

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