Emergent BioSolutions Announces Submission to FDA of Application Covering Emergency Use Authorization for NuThrax

Emergent BioSolutions (NYSE:EBS) announced the submission of an application to the U.S. Food and Drug Administration (FDA) for potential emergency use of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) in the event of a public health emergency involving Bacillus anthracis.

As quoted in the press release:

“We are pleased with engaging in early discussions with the FDA regarding this EUA package submission for NuThrax, which has been identified as a potential critical component of the nation’s anthrax preparedness strategy,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “NuThrax is designed to have attractive features, including the potential to have a shorter dosing schedule and to elicit a faster immune response, that may make it a more appropriate candidate for an effective response to a large-scale public health emergency involving anthrax. We look forward to NuThrax being an EUA-eligible product to enable deliveries to the Strategic National Stockpile in 2019.”

NuThrax is comprised of Anthrax Vaccine Adsorbed in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. NuThrax was designed to have a two-dose schedule and may elicit a faster immune response than currently available anthrax vaccines. Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of NuThrax.

Click here to read the full press release.