SIGA Technologies, Inc. products
Post-Exposure Prophylaxis (PEP)
Post-exposure prophylaxis (PEP) regimens are designed to block or reduce impact of infections in individuals who have known or potential exposure to an infectious agent but are not symptomatic. Such regimens have been used successfully for other infections. In October 2018, SIGA entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) with a focus on Good Laboratory Practice (GLP) studies of TPOXX® for PEP using a U.S. Food and Drug Administration (FDA)-approved non-human primate model of TPOXX® efficacy against smallpox infection. In July 2019, SIGA was awarded a multi-year contract from the United States Department of Defense (DoD) to support work necessary to gain a potential label expansion for TPOXX® that would include PEP of smallpox.
SIGA - Vaccines for Smallpox
Oral TPOXX® (tecovirimat) is the first drug approved by the U.S. Food and Drug Administration (FDA) that is specifically indicated for the treatment of smallpox disease in adults and pediatric patients weighing at least 13 kg. (Prescription Label) TPOXX® inhibits viral maturation of variola virus (the virus that causes smallpox) and other poxviruses by preventing the formation of a secondary viral envelope. In the absence of this envelope, viral particles remain inside the cell and cannot spread to and infect other cells. The most frequently reported adverse reactions were headache and nausea.
Liquid Suspension Pediatric Formulation
Not all patients are able to swallow TPOXX capsules, the currently-approved oral formulation. To address this unmet need, particularly for pediatric patients weighing less than 13kg who are not covered by the approved label indication for oral TPOXX, SIGA has embarked on a program to develop an oral liquid suspension formulation with funding and support from BARDA. Formulation prototypes have been generated and will undergo clinical evaluation.
TPOXX - Injection for Smallpox
SIGA has developed TPOXX® Injection, an intravenous (IV) formulation of TPOXX® for those patients who are too sick or unable to swallow oral capsules. SIGA completed clinical trials for the IV formulation with funding from the Biomedical Advanced Research and Development Authority (BARDA). In April 2021, SIGA submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for IV TPOXX®. It was formally approved by FDA in May 2022.