Emergent BioSolutions announced that the Food and Drug Administration (FDA) has approved Anthrasil (anthrax immune globulin intravenous [human]) also known as AIGIV, for the treatment of inhalation anthrax in combination with appropriate antibacterial drugs.
Anthrasil is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis. It is prepared using plasma collected from healthy, screened donors who have been immunized with BioThrax (anthrax vaccine adsorbed).
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The efficacy of Anthrasil was studied in animals due to feasibility and ethical issues with conducting adequately controlled efficacy studies in humans. After exposure to a lethal aerosolized dose of B. anthracis spores, rabbits and monkeys were treated with Anthrasil or placebo. Survival in monkeys treated with Anthrasil ranged from 36–70% vs. 0% in the placebo group, with a trend towards increased survival with higher doses of Anthrasil. Rabbits receiving a moderate Anthrasil dose had a 26% survival rate vs. 2% in the placebo group. In another study, a combination of Anthrasil and antibiotics led to a 71% survival rate in rabbits vs. 25% in animals treated with antibiotics alone. These results provided sufficient evidence that Anthrasil is reasonably likely to benefit humans with inhalation anthrax. The safety of Anthrasil was tested in 74 healthy human volunteers; the most commonly observed side effects were headache, back pain, nausea, and infusion site pain and swelling.
Anthrasil was granted Orphan Drug designation by the FDA in 2008 and was developed as part of a contract with the Biomedical Advanced Research and Development Authority (BARDA).
For more information visit FDA.gov.