FDA Grants Priority Review for Smallpox Treatment

The Food and Drug Administration (FDA) has accepted and granted priority review to the New Drug Application (NDA) for TPOXX, an antiviral therapy for smallpox. There is currently no treatment approved for smallpox infection. 

TPOXX (tecovirimat; SIGA Technologies) is a novel small molecule orally-administered antiviral. The treatment was developed under the FDA’s ‘Animal Rule’ where efficacy is determined in animal studies and human studies determine safety and appropriate dosing. 

“Our public-private collaboration serves as an important example of how such partnerships can advance novel drugs for unmet medical needs,” said Dr Phil Gomez, CEO of SIGA. 

“Eventual approval of this product would be an important step in advancing health security against the serious threat of a potential smallpox-based bioterror attack.” 

SIGA received funding to complete the development of TPOXX from the US government’s Biomedical Advanced Research and Development Authority (BARDA). Although not yet approved, BARDA has already purchased 2 million courses of TPOXX, which have been delivered to the Strategic National Stockpile (SNS).

The FDA has stated a target action date for TPOXX of August 8, 2018.

Reference

SIGA Technologies announces FDA accepts NDA and grants Priority Review for oral TPOXX to treat smallpox [press release]. New York, New York: SIGA Technologies. Published online Febraury 7, 2018. Accessed February 13, 2018.

This article originally appeared on MPR