SIGA Technologies Inc (NASDAQ: SIGA) has announced that it has received approval from the UK for oral tecovirimat (popular as Oral TPOXX in the US) for monkeypox, cowpox, smallpox, and vaccinia complications after vaccination against smallpox in children and adults weighing at least 13kg.
UK approves TPOXX in various use cases.
SIGA CEO Dr. 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.”
Health Canada and the US FDA both granted approval to the same tecovirimat product for smallpox treatment in late 2021 and 2018, respectively. Early this year, the European Medicines Agency granted SIGA permission to sell tecovirimat for the treatment of smallpox, cowpox, monkeypox, and complications from vaccinia infection.
SIGA focuses on the health security market
SIGA focuses on the health security sector, which comprises countermeasures for chemical, biological, nuclear, and radiological exposures, therapies, and vaccines for emerging infectious conditions and health products. TPOXX is the company’s flagship product which is an antiviral medication with oral and intravenous administration for the treatment of variola virus-induced human smallpox. TPOXX is a brand-new small-molecule medication, and the US keeps some on hand as part of Project BioShield.
In 2018 the FDA’s approved TPOXX oral medication for the management of smallpox. The European Medicines Agency (EMA) granted oral tecovirimat authorization in 2022. Oral tecovirimat’s labeling specifying that it should be used to treat smallpox, cowpox, monkeypox, and vaccinia problems following smallpox vaccination are included in the EMA approval.
Notably, in 2018, the company signed an agreement with Biomedical Advanced Research and Development Authority for additional procurement and development related to intravenous and oral TPOXX formulations.