Emergent Submits SBLA To Expand BioThrax Label - Quick Facts

(RTTNews) - Emergent BioSolutions Inc. (EBS) announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA seeking to expand the label of BioThrax to include a post-exposure prophylaxis indication. BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication only.

The company made a request for priority review designation to potentially reduce the anticipated approval of the application to six months. The sBLA proposes to expand the BioThrax indication to include a post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age.