Acambis plc announced that it has filed a Biologics License Application (BLA) with the CBER vaccine division of the US Food and Drug Administration (FDA) to seek registration in the US of its Arilvax vaccine to prevent yellow fever.
Acambis recently completed a Phase III paediatric trial of Arilvax, which provided additional data to supplement that generated from two previous Phase III adult trials.
Arilvax is a live, attenuated vaccine to prevent yellow fever. It is already registered in 10 countries, including the UK, and Acambis has the rights to market the vaccine in the US. The vaccine’s manufacturer, Chiron Vaccines, part of California-based Chiron Corporation, owns rights outside of the US.
Dr John Brown, chief executive officer of Acambis, commented: “This submission marks a major achievement for Acambis, not only because this is our first ever BLA but also because it is the first time a BLA has been submitted electronically to the CBER vaccine division of the FDA. It is another significant milestone in our plan to establish a travel vaccines franchise in North America.'
Acambis is a leading developer of vaccines to prevent and treat infectious diseases. Recognised internationally as the leading producer of smallpox vaccines, Acambis is developing a second-generation smallpox vaccine, which is currently undergoing clinical trials and, under a unique arrangement given the threat of smallpox being used as a bioterrorist weapon, is manufacturing emergency-use stockpiles of this investigational vaccine for the US government and other governments around the world. Acambis is establishing a travel vaccines franchise through its US-based subsidiary Berna Products Corporation, which markets Vivotif, the world's only oral typhoid vaccine, in North America.