Why The Fda Just Approved A Drug For Smallpox?

March 1, 2019

The Food and Drug Administration (FDA) just approved a drug to treat a disease that no longer exists…. Well, sort of.

Today (July 13), the agency announced that it has approved TPOXX (generic name: tecovirimat), the first drug to specifically treat smallpox. Yes, smallpox, a disease that was eradicated from the world in 1980, thanks to a global vaccination campaign. (Eradication means that cases of the disease no longer occur naturally).

However, the agency says that despite global eradication, there are still concerns that the smallpox virus could be used as a biological weapon.

“In response to the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be used as weapons,” said FDA Commissioner Dr. Scott Gottlieb in a statement.” Today’s approval provides an important milestone in these efforts. This new treatment provides us with an additional option if smallpox is used as a biological weapon.”

Technically, smallpox has not been completely eradicated from the planet – there are still some stocks of the virus in laboratories in the United States and Russia. According to the U.S. Centers for Disease Control and Prevention, there are concerns that in the past, some countries have made biological weapons out of the smallpox virus, which could have fallen into the wrong hands.

And in 2017, scientists in Canada announced that they had recreated a relative of smallpox, the horsepox virus, using DNA fragments in a lab. The discovery shows that scientists can also create smallpox viruses in the lab.

The FDA said the new drug was tested in animals infected with a virus closely related to the smallpox virus; however, it was not tested in people infected with a similar virus. Instead, TPOXX was approved under the FDA’s animal rule, which allows animal studies to be used to support approval when it is not feasible or ethical for the drug to be studied for effectiveness in humans. However, the drug has been tested for safety in more than 350 healthy people who did not have smallpox.