Breaking News - FDA Clears Emergent's Anthrasil

March 26, 2015

The FDA approves Emergent BioSolutions' (NYSE:EBS) Anthrasil [Anthrax Immune Globulin Intravenous (Human)] for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. The milestone triggers a $7M payment to the company from the Biomedical Advanced Research and Development Authority (BARDA). Also, its Orphan Drug status provides a seven-year period of market exclusivity for the indication.

Anthrasil is a sterile solution of purified human immune globulin G (IgG) that contains polyclonal antibodies that target the anthrax toxins of Bacillus anthracis. 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.

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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."