FDA Approves First Smallpox Treatment to Counter 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.

Before the elimination of smallpox, the virus that causes disease, Variola, was mainly spread by direct contact between individuals and had potentially severe complications that include encephalitis, corneal ulcerations, and blindness. According to the FDA, symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache, with a rash that progressively worsened from small, pink bumps to pus-filled sores before scarring.

Tecovirimat’s safety was evaluated in 359 healthy human volunteers without a smallpox infection. The most common adverse effects associated with the treatment were headache, nausea, and abdominal pain.

This aricle was originally published onSpecialityPharmacyTimes.com.

Reference

FDA approves the first drug with an indication for treatment of smallpox [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm. Accessed July 16, 2018.