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Smallpox drug: NDA submitted to FDA

SIGA Technologies, Inc. today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral formulation of TPOXX® (tecovirimat).

Image/Communicable Disease Control and Prevention, San Francisco Dept. of Public Health

TPOXX was developed to treat smallpox, as well as other orthopoxvirus infections. No cure or treatment for smallpox exists.

The advanced development of TPOXX has been funded by the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA). Pursuant to a contract with BARDA, SIGA has successfully delivered two million courses of TPOXX to the Strategic National Stockpile.

“We are very pleased to have achieved this important milestone in the development of TPOXX. If approved, TPOXX would be the first ever treatment for smallpox,” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc. “Based on extensive positive efficacy data in animal studies and human clinical safety data without any drug-related Serious Adverse Events, we believe the NDA for oral TPOXX is well positioned for favorable, expedited review by the FDA.  This is an important milestone not only for SIGA, but an important example of how public-private partnerships can advance novel drugs for unmet medical needs towards FDA licensure. This NDA filing is also an important step in advancing health security against the growing threat of a potential smallpox-based bioterror attack.”

LISTEN: Bioterrorism

TPOXX (tecovirimat) was developed under the FDA “Animal Rule,” in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing. There have been no drug-related Serious Adverse Events (SAEs) during the development of oral TPOXX.

If approved, this would be the first treatment for deadly smallpox.