Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax - Quick Facts

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Emergent BioSolutions Receives FDA approval for Supplemental Biologics License

Application for BioThrax - Quick Facts

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Emergent BioSolutions Inc. (EBS: News ) announced that FDA has approved its

supplemental Biologics License Application or sBLA for Anthrax Vaccine Adsorbed

or BioThrax to prevent disease caused by Bacillus anthracis. The approval for

supplement license was based on an interim analysis of data from a large

multicenter study initiated in 2002.

The company said 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.

Randi J. Airola, © 517-819-5926