SIGA Announces New Drug Application Filing with FDA for Intravenous Formulation of TPOXX
SIGA Technologies, Inc. has announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the intravenous formulation (IV) of TPOXX. The proposed indication, for the treatment of human smallpox disease in adults and pediatric patients weighing 13 kg or more, is the same as what was approved by the FDA in July 2018 for the oral formulation of TPOXX. The IV formulation will enable those patients who are too sick or unable to swallow capsules to be treated with TPOXX, thereby adding a significant new patient population.
“This is our first application for regulatory approval of IV TPOXX, and we are pleased to be achieving this milestone to support maximum access to the product among a broader patient population in case of an emergency or outbreak,” said Dr. Phil Gomez, CEO of SIGA. “The ongoing COVID-19 pandemic has highlighted the importance for governments to build robust stockpiles of products that will support effective responses to infectious disease outbreaks, including smallpox, which remains a significant bioterror threat and could be an even more devastating disease than COVID-19.”
“SIGA developed IV TPOXX in partnership with the U.S. government, and the combined expertise has helped generate a robust set of data supporting the NDA for the IV product,” said Dr. Dennis Hruby, CSO of SIGA. “As a result of the extensive effort that went into our initial filing with the FDA, we were not required to complete any additional pre-clinical or clinical work for our IV application. We look forward to working with the FDA so that the expanded patient population can benefit from treatment with IV TPOXX.”
On July 13, 2018, the FDA approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. TPOXX, a small-molecule antiviral treatment for smallpox, is the first therapy specifically approved for this indication, and was developed through funding and collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, as well as early stage development supported by the National Institutes of Health, U.S. Centers for Disease Control and Prevention, and Department of Defense.
On September 10, 2018, the Company entered into a contract with BARDA pursuant to which SIGA agreed to manufacture and deliver to the U.S. government, or store as vendor-managed inventory, the IV formulation of TPOXX. Additionally, the 2018 BARDA contract includes funding for advanced development of IV TPOXX, and post-marketing activities for IV TPOXX, among other activities.