FDA Approves First Drug Indicated to Treat Smallpox

Although eradicated in 1980 due to vaccination efforts, there have been concerns of the virus being used as a potential weapon in bioterrorism.

Officials with the FDA have approved tecovirimat (TPOXX, SIGA), the first drug with an indication for the treatment of smallpox, to boost preparedness in the event of a bioterror attack, according to a press release.

Although eradicated in 1980 due to vaccination efforts, there have been concerns of the virus being used as a potential weapon in 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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”

The approval is based on data from studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox. The drug’s efficacy was based on measuring survival at the end of the study. According to the data, more animals treated with tecovirimat survived compared with animals treated with a placebo. As a result, the drug was approved under the FDA’s Animal Rule, which allows the efficacy findings to support an FDA approval when it is not feasible or ethical to conduct trials in humans.

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