Emergent BioSolution's BioThrax Receives FDA Orphan Drug Designation

By Cyndi Root

Emergent BioSolutions announced in a press release that the Food and Drug Administration (FDA) has granted BioThrax an Orphan Drug Designation. The anthrax vaccine is administered after suspected or confirmed exposure to anthrax disease. Orphan status for rare conditions allows Emergent BioSolutions marketing exclusivity and other benefits. Adam Havey, EVP and President of the biodefense division at Emergent BioSolutions 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

BioThrax is a vaccine to prevent anthrax disease, indicated for people aged 18 to 65 at high risk for exposure to anthrax. BioThrax is made from a non-virulent strain of Bacillus anthracis. Emergent has been supplying the agent to the U.S. government since 1998, delivering over 66 million doses of BioThrax. Each dose of 0.5 mL is injected intramuscularly at 0, 1, and 6 months. Booster doses are injected at 12 and 18 months after initiation of the primary series, and at 1-year intervals thereafter. The vaccine may be administered subcutaneously with a slightly altered administration schedule.

BioThrax is not proven safe and effective and may not offer protection to every individual. Treatment is not complete and people not considered protected until the three part series of doses is performed. Recently, Emergent completed a non-interference study, which the company intends to use in support of its Biologics License Application (BLA). The company also intends to use the results from the study to submit a supplemental BLA to use BioThrax in combination with antibiotics to treat anthrax exposure. The study was funded by the Biomedical Advanced Research and Development Authority (BARDA).

Bacillus Anthracis

Bacillus anthracis or anthrax is an infectious disease. In a natural state, it is found in animals and soil, and can get people sick if they come in contact with it. While BioThrax is intended for people who may come in contact with the virus, the federal government could use it to respond to a suspected or confirmed anthrax terrorist event.