SIGA Technologies Inc. submitted a new drug application to the U.S. Food and Drug Administration for its smallpox treatment Tpoxx.
Tpoxx was developed to treat smallpox, as well as other orthopoxvirus infections. There is no cure or treatment approved for smallpox.
SIGA has requested an expedited review of its application. The advanced development of Tpoxx is funded by the U.S. government's Biomedical Advanced Research and Development Authority.
The drug is administered in oral form and was developed under the U.S. FDA's animal rule in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine the safety and confirm dosing.
SIGA expects a response from the U.S. FDA in February 2018.