FDA approval for Emergent BioSolutions' Anthrasil

25 March 2015

US biopharma company Emergent BioSolutions (NYSE: EBS) has received approval from the US Food and Drug Administration for its Anthrasil (anthrax immune globulin intravenous [human]), also known as AIGIV, for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

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 US government's strategic national stockpile and we are committed to working collaboratively with BARDA and CDC to further advance this program."

“Today’s approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.

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