BRIEF—FDA approves the first drug with an indication for treatment of smallpox

The US Food and Drug Administration on Friday approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.

Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.

The FDA granted approval of TPOXX to biological warfare defense firm SIGA Technologies in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

“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. 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,” said FDA Commissioner Scott Gottlieb.

"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today’s action reflects the FDA’s commitment to ensuring that the US is prepared for any public health emergency with timely, safe and effective medical products,”