FDA approves smallpox treatment as part of counterterrorism effort

The Food and Drug Administration announced it has approved a treatment for smallpox, a disease that has been largely eradicated but still feared for its possible use in biowarfare.

“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,” Dr. Scott Gottlieb, FDA commissioner, said in a statement issued Friday. “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.”

The medication is TPOXX (tecovirimat), a product of SIGA Technologies Inc. based in New York City.

Despite the existence of a vaccine, federal health officials advise people not to get it unless they live or work in an environment that would put them at risk of contracting the virus, called variola. This is narrowly limited to people working in laboratories with viruses that cause smallpox or are similar to it, according to the Centers for Disease Control and Prevention.

In the late 18th and early 19th century, countries in Europe and North America used the smallpox vaccine to bring the widespread problem under control. A 20-year global vaccine campaign brought smallpox to an end by 1980 across Africa, Asia and South America.

The virus, which is contracted through direct personal contact, causes fever, exhaustion and body aches followed by an all-over body rash. The rash progresses to pink bumps that become pus-filled sores” that then crust over and scar. Serious complications can include encephalitis (swelling of the brain), open sores and ulcers on the clear front surface of the eye and blindness.

As a treatment, TPOXX gained approval through the FDA by showing treatment efficacy in animal testings, with more infected animals who were treated with TPOXX surviving compared to untreated animals.

The safety of TPOXX was established in human trials of 359 health volunteers, the FDA said in a statement.

“This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher,” Dr. Gottlieb said. “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.”