FDA approves Emergent BioSolutions' supplemental biologics license application

ROCKVILLE, Md. — Emergent BioSolutions Inc. announced Dec. 19, 2008, that the U.S. Food and Drug Administration has approved its supplemental biologics license application for Anthrax Vaccine Adsorbed BioThrax, the only FDA-licensed vaccine to prevent disease caused by Bacillus anthracis.

The supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule for BioThrax is five intramuscular doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses at 0, 2 weeks and 1, 6, 12, 18 months.

The application was based on results from a planned interim analysis of data from a large multicenter study initiated by Centers for Disease Control and Prevention in 2002. This study is designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses up to three years apart, will confer an adequate immune response.

CDC will complete further data analysis in 2009, and Emergent BioSolutions may submit a new application to allow for further reduction in the number of required doses if supported by the data.

Daniel Abdun-Nabi, CEO and president of Emergent BioSolutions said, “Today’s announcement is an exciting milestone in our continued mission to advance BioThrax. We are pleased that the U.S. government shares our commitment to enhancing this critical countermeasure. The CDC is to