SIGA Completes Clinical Studies for IV Formulation of TPOXX, NDA to be Submitted in 2020
SIGA Technologies, Inc. announced on October 3rd that it has reached concurrence with the US Food and Drug Administration (FDA) that no further clinical studies will be required for the IV formulation of TPOXX (tecovirimat), and SIGA anticipates filing the New Drug Application (NDA) for this formulation in 2020.
Given that the efficacy of TPOXX was previously established in animal models used to support the development and approval of the oral formulation, the FDA will not require additional efficacy data to support the NDA for the IV formulation. The IV formulation of TPOXX is an important option for the treatment of smallpox in those who may be too sick or unable to swallow the oral capsule formulation.
The Biomedical Advanced Research and Development Authority (BARDA) emphasized the importance of this option in the 2018 contract award to SIGA, which specifies the delivery of 20,000 courses of the IV formulation of TPOXX and contains options for the purchase of up to an additional 192,000 courses of the formulation.
“We are pleased to reach this milestone with the FDA in the development of the IV formulation of TPOXX,” said Phil Gomez, CEO of SIGA Technologies. “We will now focus on finalizing the commercial production capability for IV TPOXX and submitting the NDA in 2020.” SIGA anticipates that the FDA will approve the IV formulation of TPOXX in 2021.
On July 13, 2018, the FDA approved the oral formulation of TPOXX (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 BARDA 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.