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Biologics Licence Application Filed for Arilvax, Yellow Fever Vaccine
Acambis recently completed a Phase III paediatric trial of ARILVAXTM, which provided additional data to supplement that generated from two previous Phase III adult trials.
ARILVAXTM 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. Rights outside of the US are owned by the vaccine's manufacturer, Chiron Vaccines, part of California-based Chiron Corporation.
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.