SIGA Technologies, Inc., announced on Wednesday that it had officially received FDA concurrence on its lead product, tecovirimat, also known as TPOXX and ST-246.
Tecovirimat is an orally administered antiviral drug that targets orthopoxvirus-related diseases, including smallpox.
The feedback from the FDA will allow SIGA to complete its Phase 3 trial study for the treatment, which is currently ongoing.
SIGA Technologies specializes in the development and commercialization of solutions for conditions that do not have a reliable source of treatment or a patient population that does not have its needs met.
Tecovirimat has not yet been licensed or designated as safe for use by the FDA. The treatment is, however, being shipped to the Strategic National Stockpile under Project BioShield.
Smallpox and other targets orthopoxvirus-related diseases are extremely dangerous and the United States has identified them as a material threat, with the Centers for Disease Control designated them as Class A pathogens.
“We are pleased to receive FDA concurrence on dosage for our clinical safety studies and look forward to the future development and distribution of this critical antiviral,” Dr. Eric Rose, SIGA’s CEO said.