Emergent BioSolutions Inc. (NYSE: EBS) announced today 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. NuThrax, also known as AV7909, is being developed as a next generation anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracisexposure, in conjunction with the recommended course of antimicrobial therapy. This submission is anticipated to undergo review by FDA through the first half of 2019.
“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.
The FDA submission package was completed under the company’s 2016 contract with the Biomedical Advanced Research and Development Authority (BARDA) that includes a five-year base period of performance valued at approximately $200 million to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile an initial three million doses following EUA pre-approval by FDA.
Contract HHSO100201600030C for the advanced development and delivery of NuThrax is funded by BARDA, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
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