Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted). AV7909 is the company's new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

The rolling BLA submission, completed in April 2022, is based on data from the pivotal phase 3 clinical study of AV7909 that evaluated the lot consistency, immunogenicity, and safety of the vaccine candidate following a two-dose schedule administered intramuscularly in healthy adults. It also included data from the phase 2 study that evaluated non-interference between AV7909 and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease. The BLA submission was completed under contract HHSO100201600030C for the advanced development and delivery of AV7909, 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.