FDA approves Tembexa for smallpox – Chimerix

Chimerix announced that the FDA has granted Tembexa (brincidofovir) tablets and oral suspension approval for the treatment of smallpox. Tembexa is approved for adult and pediatric patients, including neonates.

Tembexa’s approval is based on efficacy data in two lethal orthopoxvirus animal models of human smallpox disease, the rabbitpox model (New Zealand White rabbits infected with rabbitpox virus) and the mousepox model (BALB/c mice infected with ectromelia virus). In the pivotal studies in each model, Tembexa treatment resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose. The FDA’s ‘Animal Rule’ allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans.