Emergent BioSolutions announces submission to FDA of application covering emergency use authorisation for NuThrax

Emergent BioSolutions

28 December 2018 - Emergent BioSolutions announced today the submission of an application to the U.S. 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 anthracis exposure, in conjunction with the recommended course of antimicrobial therapy. This submission is anticipated to undergo review by FDA through the first half of 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.

Read Emergent BioSolutions press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Dossier