By IDSE News Staff
The FDA Antimicrobial Drugs Advisory Committee recommended in favor of the approval of oral tecovirimat (TPOXX, SIGA Technologies), a small-molecule antiviral treatment for smallpox and other orthopoxviruses.
The panel, comprising independent medical experts, voted unanimously (17-0) that the benefits of tecovirimat outweigh its risks.
Tecovirimat was developed under the FDA “Animal Rule,” in which efficacy end points are determined in animal studies, and human