The Food and Drug Administration has approved a new drug to treat smallpox. Tembexa (brincidofovir) tablets and oral suspension, manufactured by Chimerix, have been approved for adult and pediatric patients, including newborns.
The FDA noted that despite the eradication of smallpox in 1980, the variola virus — which causes the illness — has the potential to be used as a bioweapon. Because of this, the agency said smallpox drug development remains an important component of the U.S. medical countermeasures response.
Tembexa's effectiveness was studied in animals infected with viruses closely related to the variola virus, with more animals surviving when treated with the drug compared with those administered with a placebo. The FDA cleared Tembexa under its animal rule, which allows findings from certain animal efficacy studies to be the basis for approval if human efficacy trials are neither ethical nor feasible.
“We are delighted to report our first FDA-approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year," said Mike Sherman, CEO of Chimerix. "With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and Development Authority toward a procurement contract to support national preparedness."