Emergent BioSolutions Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.
Achievement of this milestone triggers a $7 million payment to the company under a development contract with the Biomedical Advanced Research and Development Authority (BARDA). Anthrasil has received Orphan Drug designation and as a result of this approval, the product qualifies for seven years of market exclusivity.
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, "Emergent is pleased to receive FDA approval of Anthrasil, the only FDA-approved polyclonal therapeutic for the treatment of anthrax disease. Anthrasil remains an integral part of the U.S. government's strategic national stockpile and we are committed to working collaboratively with BARDA and CDC to further advance this program."
Anthrasil is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis, the bacteria that causes anthrax disease. It is prepared using plasma collected from healthy, screened donors who have been immunized with Emergent's BioThrax® (Anthrax Vaccine Adsorbed) vaccine, the only FDA-licensed vaccine for the prevention of anthrax disease.
In support of the U.S. government stockpiling strategy for AIGIV, Emergent continues to perform under a $63 million BARDA contract awarded in 2013 for the collection and storage of anti-anthrax human plasma. This plasma is necessary for the potential future manufacture of bulk drug substance and AIGIV final drug product.
Anthrasil was developed as part of a $160 million contract with BARDA, within the office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Under this contract, which was awarded in 2005, Anthrasil has been delivered to and is stored in the U.S. Strategic National Stockpile.