First Drug, Tecovirimat (TPOXX), Approved to Treat Smallpox

MONDAY, July 16, 2018 -- TPOXX (tecovirimat) has been approved by the U.S. Food and Drug Administration to treat smallpox.

Though the contagious and often-deadly viral disease was considered eradicated by the World Health Organization in 1980, there are concerns that smallpox could be used in a terrorist attack.

"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 Dr. Scott Gottlieb said in an agency news release.

The "approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon," he added.

Symptoms of smallpox typically begin 10 to 14 days after exposure, and include fever, exhaustion, headache and backache, the agency said. The variola virus that causes smallpox also produces a rash characterized by small, pink bumps that progress to pus-filled sores. Potential complications of the disease include encephalitis (brain inflammation) and eye sores that could lead to blindness.

Citing agency rules that allow drugs to be tested in animals when human testing isn't ethical or feasible, TPOXX was evaluated in animals infected with germs that are closely related to smallpox, the FDA said. The drug's safety was evaluated in 359 people who didn't have a smallpox infection. The most common side effects among people included headache, nausea and abdominal pain.

TPOXX is produced by SIGA Technologies, based in New York City.

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Posted: July 2018