Acambis submits BLA on smallpox vaccine to US FDA

Cambridge, UK-based Acambis says that it has completed submission of a Biologics License Application to the US Food and Drug Administration to seek licensure of its investigational smallpox vaccine, ACAM2000.

As agreed with the FDA, Acambis submitted the BLA on a "rolling" basis, starting with the first portion in January 2006. This includes safety, tolerability and immunogenicity data obtained from clinical trials of ACAM2000 conducted in more than 3,800 subjects. The vaccine's program was given "fast-track" status by the US agency in December 2004.

Gordon Cameron, chief executive of Acambis, commented: "we anticipate [the BLA] will come before the end of 2006, based on ACAM2000's fast-track status."