Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Siga Technologies has submitted to the FDA an application to support an emergency use authorization of its drug ST-246, an orally active, smallpox antiviral, to treat individuals exposed to the smallpox virus in the event of an outbreak.
Subscribe to our email newsletter
The emergency use authorization (EUA) mechanism was created by Congress to enable the FDA Commissioner to authorize the use of a drug that has not been approved, or has not been approved for a particular use, when the nation is in a state of declared emergency. EUA approval is given only to those drugs or products that may be effective in the prevention, diagnosis or treatment of serious or life-threatening diseases or conditions that can be caused by specified biological, chemical, radiological or nuclear agents.
The drug ST-246 has previously shown significant antiviral activity in numerous animal models of orthopoxvirus disease, including the complete protection of primates from lethal doses of monkeypox and smallpox virus.
Eric Rose, CEO and chairman of Siga, said: “Based on the success to date of our product candidate in trials, we believe that we have the most advanced smallpox treatment in development, and that ST-246 represents the most effective treatment option should a smallpox threat ever arise.”