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news.UK vaccine maker Acambis has completed its submission of a biologics license application to the FDA seeking licensure of its investigational smallpox vaccine, ACAM2000.
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Acambis submitted the application on a rolling basis, starting with the first portion in January 2006. The BLA includes safety, tolerability and immunogenicity data obtained from clinical trials of ACAM2000 conducted in more than 3,800 subjects.
The ACAM2000 program was given fast-track status by the FDA in December 2004. Based on this fast-track designation, the FDA should complete its review before the end of 2006.
“I’m very proud of Acambis’ achievement in completing the ACAM2000 BLA submission just three-and-a-half years after ACAM2000’s investigational new drug application was submitted,” said Gordon Cameron, CEO of Acambis.
Acambis is manufacturing emergency-use stockpiles of ACAM2000 for the US government and other governments around the world.