The UK health regulator indicated Tecovirimat for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications, after vaccination against smallpox in adults and children
SIGA gets regulatory approval for Tecovirimat in the UK. (Credit: Afif Kusuma on Unsplash)
SIGA Technologies announced that its antiviral drug tecovirimat has been approved in the UK for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications.
The drug is indicated for reducing the complications after vaccination against smallpox in adults and children.
Tecovirimat is a novel small-molecule drug marketed in the US under the brand name TPOXX, used both as an orally administered and IV formulation, to treat human smallpox disease.
The antiviral drug has been approved by the US Food and Drug Administration (FDA) in 2018 and by Health Canada last year, for the treatment of smallpox.
Earlier this year, SIGA received European Medicines Agency (EMA) authorisation for tecovirimat for the indication same as the current approval in the UK.
SIGA CEO Phil Gomez said: “We are very pleased that the UK has taken this important step in health emergency preparedness, not just for the immediate need in the current monkeypox outbreak, but for broader readiness by approving tecovirimat for treatment for a wide range of uses.
“As we have learned in the ongoing Covid-19 pandemic, building robust stockpiles in response to infectious disease outbreaks is of vital importance worldwide. This includes being ready to combat even more devastating bioterror threats such as smallpox.”
SIGA is a US-based pharmaceutical company focused on the countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness.
In September 2018, the company signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for additional procurement of both oral and IV formulations of TPOXX.
Last month, SIGA announced received procurement orders worth around $13m for the oral formulation TPOXX (tecovirimat).