Emergent BioSolutions completes BioThrax PEP clinical study

Emergent BioSolutions, Inc., announced on April 16 that it successfully completed a licensure-enabling study for its anthrax vaccine and submitted the study report to the U.S. Food and Drug Administration.

The study was the last in Emergent's BioThrax post-exposure prophylaxis program. It was a non-interference study meant to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered before and after the administration of a three-dose series of BioThrax. The study was also designed to evaluate BioThrax's immune response when administered with or without ciprofloxacin.

Emergent found that BioThrax met the primary and secondary endpoints for the study. Data from the clinical trial showed no interaction between BioThrax and ciprofloxacin.

Emergent submitted the final clinical study report to the FDA and the Biomedical Advanced Research and Development Authority.

"Emergent is pleased with the positive results of this non-interference study and BARDA's approval of the final clinical study report, which is a contractual milestone in our BioThrax PEP program," Adam Havey, the executive vice president and president of Emergent's biodefense division. said. "We look forward to having a pre-(biologics license application) meeting with FDA this quarter and submitting the supplemental application for a PEP indication for BioThrax in the fourth quarter."

Emergent is seeking licensure to use BioThrax in combination with antibiotics in people with confirmed or suspected exposure to anthrax spores. It is currently licensed for a pre-exposure prophylaxis indication only. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.

Results of the recent study will be published on April 17 in Vaccine.