FDA grants orphan drug status to Emergent BioSolutions, Inc.’s BioThrax

The U.S. Food and Drug Administration (FDA) granted orphan drug status to Emergent BioSolutions, Inc., on Wednesday for BioThrax (anthrax vaccine adsorbed) for post-exposure prophylaxis of anthrax disease from suspected or confirmed exposure to Bacillus anthraces.

BioThrax is the only FDA-licensed vaccine for anthrax disease. It is indicated for both pre- and post-exposure prophylaxis of anthrax disease.

“BioThrax plays a significant role in the U.S. government’s biosecurity efforts and Emergent is pleased to receive FDA orphan drug exclusivity, which recognizes our commitment to enhancing the features of BioThrax, in particular, the additional indication of post-exposure prophylaxis of anthrax disease to which the orphan drug exclusivity applies,” Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, said.

The orphan drug status gives Emergent BioSolutions market exclusivity through Nov. 2022 for BioThrax, which is seven years from the date on which the FDA approved the PEP indication for BioThrax. Special status is provided by the Orphan Drug Designation program for drugs and biologics to treat or prevent rare medical conditions, with a specific focus on conditions affecting fewer than 200,000 people in the U.S.

Emergent BioSolutions has supplied the Strategic National Stockpile with BioThrax since 2001 in support of the U.S. government’s biosecurity and preparedness efforts.