The commercial-stage pharmaceutical company SIGA Technologies, Inc. has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for the intravenous formulation (IV) of TPOXX.
The proposed NDA to treat human smallpox disease in adults and pediatric patients is the same as what the FDA approved in July 2018 for the oral formulation of TPOXX. The IV formulation would enable patients who are too sick or unable to swallow capsules to be treated with TPOXX.
“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,” SIGA CEO Phil Gomez said. “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.”
Smallpox is a contagious, disfiguring, and often deadly disease that has impacted humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980 via an unprecedented global immunization campaign.
“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,” SIGA CSO Dennis Hruby said. “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.”