The U.S. Food and Drug Administration (FDA) has just approved a treatment for smallpox. According to the World Health Organisation, there hasn’t been a known natural infection from smallpox since 1977, but the US government has had concerns that it could be used as a bioweapon. The original article is published here, on the FDA’s website.
Smallpox is an ancient disease that was declared eradicated by the World Health Organisation (WHO) in 1979.
Its symptoms include a fever and fatigue, followed by a rash. Historically, up to 30% of people infected with smallpox died from the disease. According to the WHO, the last known natural case of smallpox was in Somalia in 1977, and, following this, the only other known cases were the result of a laboratory experiment in England in 1978, which resulted in a limited outbreak and the death of one person. A vaccination program led to the eradication of the disease, and now the smallpox vaccine is no longer routinely given out.
There are only two known stocks of smallpox in the world, both in secure laboratories. However, concerns have been raised that smallpox could be released as a bioweapon. To protect against this risk, the FDA has approved TPOXX (tecovirimat) as a treatment for smallpox.
TPOXX is an antiviral drug that was developed in collaboration between SIGA Technologies Inc. and the US Department of Health and Human Services.
It has been awarded Orphan Drug designation, as well as a Material Threat Medical Countermeasure Priority Review Voucher. It is the first product to ever receive this Material Threat voucher, which provides benefits to developers working on medical products that could be used to treat or prevent harm from certain biological, chemical, radiological, and nuclear threats.
How TPOXX Was Researched
Since researchers couldn’t test the drug’s safety and effectiveness on people with smallpox, it had to be evaluated in other ways.
The drug was studied in animals that had a virus very similar to the one that causes smallpox. It was found that infected animals treated with TPOXX had a higher survival rate than those taking a placebo.
To establish the safety of the drug in humans, 359 healthy, smallpox-free volunteers were given TPOXX. The most commonly reported side effects of the drug included headaches, feeling sick, and abdominal pain.
TPOXX has now been approved using the FDA’s Animal Rule. This allows regulators to approve drugs based on animal studies when it isn’t possible to treat people with the drug for ethical or practical reasons.