Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the United States. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years.

 

“Emergent is pleased with FDA’s Orphan Drug Designation of BioThrax for post-exposure prophylaxis,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “This designation will help streamline discussions around regulatory requirements at our pre-BLA meeting with FDA next month. We look forward to discussing our supplemental application for the expanded indication of post-exposure prophylaxis and the role of BioThrax in the treatment of inhalation anthrax.”

 

BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication. Emergent recently announced completion of a non-interference study, results from which will be used to support a supplemental BLA seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. This study is fully funded by the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

 

Date: April 21, 2014

Source: Emergent BioSolutions