Emergent BioSolutions, Inc. has submitted an IND application with the FDA for its Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. Pending the FDA’s 30-day review period, the company expects to begin a clinical trial this year to evaluate the safety and pharmacokinetics of AIG in more than 100 healthy volunteers.

“The filing of this IND for our AIG product candidate is a significant step as we continue to expand our anthrax biodefense product franchise, which includes BioThrax (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax and an enhanced anthrax vaccine,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack.”

Once initiated, the company anticipates that the trial for AIG will be completed within a year and that no additional trials will be required prior to submitting for marketing approval.