Emergent BioSolutions initiates Phase 2 study to evaluate BioThrax Emergent BioSolutions announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. The primary objective of this Phase 2 study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013.
FDA approves new indication for BioThrax The U.S. FDA approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine's new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure. BioThrax is manufactured by Emergent BioDefense Operations Lansing, based in Lansing, Michigan. Reference Link