Emergent BioSolutions said Tuesday that the U.S. Food and Drug Administration has completed its pre-approval inspection of Emergent's large-scale facility for making BioThrax, a vaccine for pre-exposure protection against anthrax.
"Emergent is pleased to have reached this critical milestone in our BioThrax comparability program," Adam Havey, executive vice president and president of biodefense division at Emergent, said in the press release.
The company said it looks forward to "timely completing" the process of securing its FDA license for the facility, which is in Lansing, Michigan. A decision is expected by August, the company said.
BioThrax is the only approved anthrax vaccine in the U.S. The company has been supplying it to the Centers for Disease Control and Prevention as part of an effort to develop a U.S. stockpile in the event of a terrorist attack.
Anthrax is an infection caused by a spore-forming bacterium. It mainly effects animals, but humans can contract the infection through contact with infected animals or inhaling spores. Inhaled anthrax can be hard to treat and can be fatal.
Emergent's stock has dropped slightly this year, falling more than 1 percent. The company's shares were mostly unchanged, but were moving back and forth between positive and negative territory.