FDA approves new smallpox drug

Avatar By Joseph Scalise | 2 years ago

The Food and Drug Administration have approved a smallpox drug despite the fact that the disease has been eradicated for nearly 40 years.

Tpoxx — also known as tecovirimat — is the first drug ever made to specifically treat smallpox. While a global vaccination campaign successfully eliminated the pathogen years ago, the reason for the new drug is that officials want to be prepared should it ever come back.

Organizations have long worried about the possibility of smallpox being used as a bioweapon. Tpoxx can be employed if such a situation ever arises.

“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,” said Dr. Scott Gottlieb, commissioner of the FDA, according to Live Science. “Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon.”

Researchers from SIGA Technologies — the company that created Tpoxx — tested the drug in animals infected with viruses closely related to smallpox. Though it was not tested in people, the FDA approved it under the rule that animal studies can support approval if it is not possible to test on humans.

While smallpox is not present in global populations, it technically still exists. Officials keep two stocks in special labs in both Russia and the United States. As a result, the Centers for Disease Control and Prevention want to be careful just in case any samples ever fall into the wrong hands.

The drug will be kept on hand should that ever happen.

“Additionally, under Project Bioshield, BARDA has acquired two million courses of oral Tpoxx and such courses have been delivered to the strategic national stockpile,” said SIGA Technologies, according to NBC News.