The first smallpox treatment, being developed for the United States government in the case of a bioterrorism attack, could be available as early as August.
FDA granted priority review of TPOXX (SIGA Technologies), an oral antiviral treatment for smallpox, and the agency’s Antimicrobial Drugs Advisory Committee voted unanimously that the benefits of TPOXX outweigh its risks.
“There are currently no approved therapies for the treatment of active smallpox disease,” Phil Gomez, PhD, CEO of SIGA Technologies, told FormularyWatch.
FDA has said it will take action on the drug by August 8, 2018.
SIGA has a $472 million procurement and development contract with the US government’s Biomedical Advanced Research and Development Authority (BARDA) for 2 million courses of oral TPOXX.
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However, SIGA plans to work with FDA and determine if there is a market demand that would support TPOXX availability through typical pharmaceutical marketing channels following FDA approval, Gomez said.
“During the recent FDA Advisory Committee meetings, panel members pointed out there may be additional important indications that SIGA should explore for TPOXX after the NDA is approved. These included the use of TPOXX in outbreaks of monkeypox, which have occurred in Africa, and the use of TPOXX in post-exposure prophylaxis, essentially treating those potentially exposed to smallpox, but not yet symptomatic,” Gomez said.
SIGA also has a development contract with the US government for an intravenous formulation of TPOXX, for individuals who cannot take TPOXX capsules.