Emergent BioSolutions submits license application for anthrax immune globulin

Emergent BioSolutions, Inc., a specialty biopharmaceutical company, announced on Thursday that it submitted a biologics license application to the U.S. Food and Drug Administration (FDA) for anthrax immune globulin intravenous (human) (AIGIV).

The application is part of a development contract between Emergent and the Biomedical Advanced Research and Development Authority (BARDA). Emergent is developing AIGIV as an intravenous therapeutic treatment for inhalation anthrax. The company acquired AIGIV in the Cangene acquisition.

"This accomplishment is a testament to the diligent work of our employees within the recently acquired Cangene operations and their years of successful collaboration and partnering with the U.S. government," Adam Havey, the executive vice president and president of the biodefense division at Emergent, said. "We commend BARDA for their steadfast commitment to advancing this key anthrax countermeasure program and remain dedicated to supporting their mission to protect our civilian and military population."

AIGIV is a solution of purified human immune globulin G that contains polyclonal antibodies that target the anthrax toxins of Bacillus anthracis. The solution is prepared using plasma collected from donors who were immunized with BioThrax, the only FDA-licensed vaccine for the prevention of anthrax disease.

AIGIV is being developed as part of a $160 million contract with BARDA. Under the contract, 10,000 doses of AIGIV were delivered to the U.S. Strategic National Stockpile. Emergent will receive a $7 million milestone payment upon FDA approval of AIGIV.

The FDA granted orphan drug designation to AIGIV in 2008.

Emergent develops specialized products to governments and healthcare providers to address emerging health threats and medical needs.

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U.S. Food and Drug Administration (FDA)

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