FDA Approves New Smallpox Drug

The FDA has approved Chimerix’s Tembexa (brincidofovir) as a treatment for smallpox — which was formally declared eradicated by the World Health Organization in 1980 but remains a threat as a potential bioweapon.

The agency said there have been serious concerns that the variola virus, which causes smallpox, could be released from a research laboratory, making smallpox drug development an important component of U.S. medical countermeasures.

Tembexa’s efficacy was determined by studying animals infected with viruses like the variola virus. The FDA can accept findings from animal studies when clinical studies in humans are unable to take place.