The Food and Drug Administration (FDA) yesterday approved Emergent BioSolutions’ infusible drug Anthrasil for use in combination with antibiotics to treat inhalational anthrax, which happens when bacterial spores that carry anthrax are breathed in.
When inhaled, anthrax bacteria reproduce in the body and produce toxins, which can cause irreversible tissue damage and eventually, death.
While inhalational anthrax is a rare disease, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) funded the drug’s development with the idea in mind of a potential future anthrax attack. BARDA stockpiles vaccines, drugs and equipment for use during pandemics and health emergencies.
Emergent BioSolutions developed the treatment as part of a $160 million contract it signed in 2005 with BARDA, reports Reuters.
Anthrasil is manufactured from the plasma of people who’ve been vaccinated against anthrax, and now carry antibodies against the bacteria. These healthy, screened donors have been immunized with Emergent BioSciences’ Anthrax vaccine, BioThrax, the only FDA-licensed vaccine for the disease.
The FDA approved the drug based largely on efficacy data from animal studies since, for ethical reasons, Anthrasil was never tested for efficacy in humans. The plasma treatment did prove well tolerated in a safety study on 74 healthy human volunteers, according to the agency.
Filed Under: Drug Discovery