The FDA Approved an Anti-Bioterrorism Drug Meant to Treat Smallpox

The Food and Drug Administration (FDA) on Friday approved the first drug specifically designed to treat smallpox — despite the fact that the disease was officially eradicated in 1980.

While the daily threat of smallpox, which is caused by the variola virus, is virtually non-existent, FDA Commissioner Scott Gottlieb said in a statement that the drug, called TPOXX, or tecovirimat, could be a safeguard against bioterrorism.

“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” Gottlieb said. “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”

TPOXX’s efficacy was tested on animals with viruses closely resembling the variola virus under the FDA’s Animal Rule, which decrees that well-designed animal studies can be used in place of human trials when it would not be safe or ethical to test a drug on people. The drug’s safety was also tested on almost 360 human volunteers, who did not have smallpox.

Tecovirimat, which is made by SIGA Technologies Inc., is the first in an upcoming string of approvals meant to reduce the risk of bioterrorism, Gottlieb said in the FDA’s announcement.

“This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher,” Gottlieb said.
“Today’s action reflects the FDA’s commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe and effective medical products.”