If approved, TPOXX would be the first available therapy for smallpox.
The US Food and Drug Administration (FDA) announced a favorable outcome for SIGA Technologies’ oral smallpox therapy tecovirimat (TPOXX), a small molecule antiviral treatment for smallpox.
The panel voted unanimously 17—0 that the benefits of TPOXX outweigh its risks. If approved, TPOXX would be the first available therapy.
“We are pleased that the advisory panel believes strongly in the benfits of TPOXX,” Phil Gomez, PhD, chief executive officer, SIGA Technologies, said in a statement. “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 new drug application support TPOXX’s future use as a medical countermeasure in response to a smallpox outbreak.”
The FDA previously announced that the final action date, pending the new drug application (NDA), is Aug. 8, 2018.
In December 2017, SIGA submitted the NDA to the FDA, seeking indications to treat other orthopoxvirus infections.
The oral formula received funding from the US government’s Biomedical Advanced Research and Development Authority (BARDA). Under Project Bioshield, BARDA has acquired 2 million courses of oral TPOXX, which have been delivered to the Strategic National Stockpile (SNS).
While there is no cure or treatment for smallpox, a vaccine can prevent the disease however, the risk of the vaccine’s side effects is too high to justify routine vaccination for those at low risk of exposure to the virus.
TPOXX was developed under the FDA’s ‘Animal Rule,’ which allows the efficacy of a therapy to be evaluated in animal trials and human clinical trials to determine safety and dosing regimens. This far, there have been no drug-related serious adverse effects reported.