FDA approves Tembexa to treat smallpox
Today, the FDA approved Tembexa to treat smallpox.
Due to “longstanding concerns” of possible weaponization of the variola virus, which is the cause of smallpox, Tembexa (brincidofovir; Chimerix) was approved under the FDA Animal Rule. The rule allows research from animal efficacy studies to serve as the basis of an FDA approval when it is neither feasible nor ethical to conduct human trials on efficacy.
In the animal study, the efficacy of brincidofovir was defined by measuring the animals’ survival by the end of the studies. Results demonstrated that more animals with smallpox who were treated with brincidofovir survived compared with animals who were treated with the placebo.
Tembexa was developed along with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. Previously, brincidofovir received priority review, fast track and orphan drug designations.
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