FDA to review biologics license application for Emergent BioSolutions anthrax vaccine candidate

With the acceptance of a biologics license application (BLA) from Emergent BioSolutions Inc. last week, the United States Food and Drug Administration (FDA) is set to review the potential of AV7909, an anthrax vaccine candidate.

“Over the last 20 years, Emergent has partnered with the U.S. government to lead this program from early- to advanced-stage development,” Kelly Warfield, senior vice president of research and development at Emergent BioSolutions, said. “As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government’s overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health.”

AV709 is evaluated for post-exposure prevention of disease following exposure to Bacillus anthracis. The vaccine is to be administered alongside recommended antibacterial drugs for adult patients between 18 and 65 years old. Both phase 3 and phase 2 studies of the drug have been undertaken. Data charting the vaccine’s consistency, immunogenicity, and safety following a two-dose schedule formed the basis of the rolling BLA submitted in April.

Phase 2 testing also critically showed that the vaccine did not interfere with antibacterial drugs already approved for post-exposure prophylaxis of anthrax disease.