Medication Monitor

Generic Name (Trade Name—Company)
July 17, 2018


(Tpoxx—SIGA Technologies)
FDA approves first drug with an indication for treatment of smallpox

FDA has approved tecovirimat, the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.

Prior to its eradication in 1980, variola virus, the virus that causes smallpox, was mainly spread by direct contact between people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache. A rash initially consisting of small, pink bumps progressed to pus-filled sores before finally crusting over and scarring. Complications of smallpox could include encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye) and blindness.

Tecovirimat's effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox and was based on measuring survival at the end of the studies. More animals treated with tecovirimat lived compared with the animals treated with placebo.

It was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

Safety of the agents was evaluated in 359 healthy human volunteers without a smallpox infection. The most frequently reported adverse effects were headache, nausea, and abdominal pain.