FDA approves the first drug with an indication for treatment of smallpox

FDA has approved tecovirimat (TPOXX—SIGA Technologies Inc.), the first drug with an indication for treatment of smallpox, the agency said Friday. The World Health Organization declared smallpox eradicated in 1980; however, there is concern that it could be used as a potential bioweapon.

FDA has approved tecovirimat (TPOXX—SIGA Technologies Inc.), the first drug with an indication for treatment of smallpox, the agency said Friday. The World Health Organization declared smallpox eradicated in 1980; however, there is concern that it could be used as a potential bioweapon. "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. 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," said FDA Commissioner Scott Gottlieb, MD. The drug's efficacy against smallpox was established in studies using animals infected with viruses that are closely related to the virus that causes smallpox. More animals treated with tecovirimat lived compared with animals that received placebo. Meanwhile, the drug's safety was tested in more than 350 healthy human volunteers without a smallpox infection. The most common adverse effects reported were headache, nausea, and abdominal pain. Tecovirimat was developed in conjunction with the Biomedical Advanced Research and Development Authority at HHS.