Emergent BioSolutions Inc. is asking the U.S. Food and Drug Administration (FDA) to allow it to include a post-exposure prophylaxis (PEP) indication on its BioThrax label, the company announced on Monday.
BioThrax is the only FDA-approved vaccine against anthrax. Currently, BioThrax is only approved for pre-exposure prophylaxis indications.
If Emergent's supplemental Biologics License Application (sBLA) is approved, the treatment for individuals already exposed to anthrax would change. Patients ages 18 to 65 would be subject to quarantine as well as the currently approved antimicrobials routine. While in quarantine, the vaccination schedule would include three doses of BioThrax at weeks 0, 2 and 4.
The change is based on data from 12 non-clinical tests and three Phase 2/3 clinical tests as well as supportive data presented at a 2010 pre-Phase 3 Vaccines and Related Biological Products Advisory Committee meeting.
The Biomedical Advanced Research and Development Authority in the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response funded the data studies.
"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,” Adam Havey, executive vice president and president of the biodefense division at Emergent, said. “To date, these efforts have led to an enhanced route of administration, a streamlined vaccination schedule and an extended shelf life for BioThrax. The next milestones for this collaboration are an expanded product label to include PEP and an increase in our manufacturing capacity to a target of between 20-25 million doses per year.”
As part of the sBLA application, the company is seeking a Request for Priority Review Designation to reduce the amount of time needed to approve the change to approximately six months.