SIGA Technologies, Inc. (SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, announced this week on a favorable outcome of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee meeting on oral TPOXX®, a small molecule antiviral treatment for smallpox. The panel, comprised of independent medical experts, voted unanimously, 17 to 0, that the benefits of TPOXX outweigh its risks.
“We are pleased that the advisory panel believes strongly in the benefits of TPOXX. We are confident that the robust data package and safety profile with no drug-related serious adverse events positions TPOXX for favorable FDA review of its pending New Drug Application (NDA).” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc. “The support of the independent medical experts that comprise the advisory committee panel provides valuable additional feedback reflecting the strength of our application for TPOXX. We believe that safety and efficacy data contained in the NDA support TPOXX’s future use as a medical countermeasure in response to a smallpox outbreak.”
The FDA has previously announced that its target final action date for the oral TPOXX NDA is August 8, 2018.
The U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) funded the advanced development of oral TPOXX in partnership with SIGA. Additionally, under Project Bioshield, BARDA has acquired two million courses of oral TPOXX and such courses have been delivered to the Strategic National Stockpile (SNS).