A New Drug Application has been submitted to the US Food and Drug Administration (FDA) for the oral formulation of TPOXX® (tecovirimat), a medication developed by SIGA Technologies to treat smallpox and other orthopoxvirus infections.
If approved by the FDA, TPOXX would be the first treatment for smallpox. The development of this medication has been funded by the US government’s Biomedical Advanced Research and Development Authority (BARBA). SIGA has delivered 2 million courses of TPOXX to the Strategic National Stockpile in accordance with their contract with BARBA.
The application filing is “an important step in advancing health security against the growing threat of potential smallpox-based bioterror attack,” stated Phil Gomez, PhD, Chief Executive Officer of SIGA Technologies.
SIGA expects to receive notification from the FDA by February 2018 that the filing was accepted for review, confirmation of priority review status, and notification of its final action date. The company had requested expedited review of TPOXX, given that the medication is designed to treat a medical condition for which there is no approved therapy.
TPOXX was developed under the FDA’s “Animal Rule,” where efficacy is determined in animal studies and safety and dosing are determined in human clinical trials. SIGA notes that there have been no drug-related serious adverse events during the development of oral TPOXX.
SIGA technologies announces FDA submission of its New Drug Application for oral TPOXX (tecovirimat) to treat smallpox [press release]. New York, New York: SIGA Technologies. http://investor.siga.com/news-releases/news-release-details/siga-technologies-announces-fda-submission-its-new-drug. Published December 11, 2017. Accessed December 12, 2017.