FDA OKs 1st drug to treat smallpox, in case of terror attack
16 Juillet, 2018, 03:25 | Auteur: Yves Courtet
Manufactured by SIGA Technologies, an OR pharmaceutical company with research in the biodefense arena, TPOXX proved effective in animal studies conducted on viruses that are closely related to smallpox.
Even though smallpox was eradicated in 1980, there have been longstanding concerns that it could be used to hurt others. "This new treatment affords us an additional option should smallpox ever be used as a bioweapon", said FDA Commissioner Scott Gottlieb, M.D.
It's the first anti-bioterror drug to win approval under the government's Material Threat Medical Countermeasure program, Gottlieb said. They reported that more animals that were administered tecovirimat had survived versus those treated with placebo.
Smallpox is caused by the variola virus and is capable of spreading through direct contact between people. Symptoms would usually start 10 to 14 days after the infection, including fever, exhaustion, and headaches.
The approval "reflects the FDA's commitment to ensuring that the USA is prepared for any public health emergency with timely, safe and effective medical products", he added.
Symptoms of smallpox are fever, fatigue, and sores filled with pus.
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Complications commonly associated with smallpox included encephalitis, corneal ulcerations, and blindness.
According to the FDA, these studies were performed under the Animal Rule, which allows animal studies to be used to support approval "when it is not feasible or ethical to conduct efficacy trials in humans".
For drugs to treat diseases such as smallpox, which can not ethically be tested in people by infecting them on objective, the FDA has special rules. In the human safety trials, the most frequently reported side effects were headache, nausea and abdominal pain.
SIGA develops vaccines and medicines for biological, chemical, radiological and nuclear attacks. TPOXX (tecovirimat) is now the world's first drug created to treat smallpox and was approved on July 13, according to an announcement by the FDA.
"Today's action reflects the FDA's commitment to ensuring that the U.S.is prepared for any public health emergency with timely, safe and effective medical products".
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