The World Health Organization declared smallpox to be eradicated way back in 1980. However, many antiterrorism experts worry that radical groups can use the disease to wipe out populations who may never have been inoculated against it. That helps explain the attention the FDA received when it approved tecovirimat (TPOXX) on July 13 to treat smallpox. FDA Commissioner Scott Gottlieb said in a statement: “This new treatment affords us an additional option should smallpox ever be used as a bioweapon.” Tecovirimat is the first drug the FDA has approved that has an indication as a treatment for smallpox.
The FDA had granted tecovirimat’s application Fast Track, Priority Review, and Orphan Drug designations. It also gave the drug a Material Threat Medical Countermeasure Priority Review voucher.