Emergent BioSolutions Inc. today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the label of BioThrax (Anthrax Vaccine Adsorbed) to include a post-exposure prophylaxis (PEP) indication.
BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication only.
“This sBLA submission reflects years of collaboration between Emergent and the U.S. government to enhance the country’s preparedness to meet immediate public health needs in the event of an anthrax attack,” said Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions. “To date, these efforts have led to an enhanced route of administration, a streamlined vaccination schedule and an extended shelf life for BioThrax.”
Havey said the next milestones for the vaccine are an expanded product label to include PEP and an increase in manufacturing capacity to a target of between 20-25 million doses per year.
The sBLA proposes to expand the BioThrax indication to include a post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age.
The vaccination schedule consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure. This indication is supported by data from twelve non-clinical studies, three Phase 2/3 clinical trials, and a 2010 pre-Phase 3 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting during which the regulatory pathway for licensure of anthrax vaccines for PEP was established.
All studies supporting licensure were fully 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.
Source: Emergent BioSolutions, adapted. BioThrax is a registered, protected term by Emergent BioSolutions.
Editor’s Note: Emergent BioSolutions was also recently awarded by BARDA $29,184,146 for development of thermostable dry-formulation biodefense vaccines.