Emergent BioSolutions' BioThrax receives orphan drug designation for PEP

Emergent BioSolutions, Inc., announced on Monday that the U.S. Food and Drug Administration granted orphan drug designation to BioThrax for post-exposure prophylaxis of anthrax disease from exposure to Bacillus anthracis.

The FDA gives orphan status to biologics and drugs being developed to treat rare medical conditions, specifically conditions affecting less than 200,000 people in the U.S. The designation waives the biologics license application supplemental regulatory filing fee and provides marketing exclusivity for up to seven years.

"Emergent is pleased with FDA's orphan drug designation of BioThrax for post-exposure prophylaxis," Adam Havey, the executive vice president and president of Emergent's biodefense division, said. "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 is the only FDA-licensed vaccine to prevent anthrax disease. The vaccine is licensed for a pre-exposure prophylaxis indication. Emergent is seeking a BLA to license BioThrax for a post-exposure prophylaxis indication to be used in combination with antibiotics in people with suspected or confirmed anthrax spore exposure.

Emergent recently completed a non-interference study to support the application. The study is completely funded under a contract provided by the Biomedical Advanced Research and Development Authority.