Emergent applies for FDA approval of anthrax vaccine

Emergent BioSolutions submitted an application to the U.S. Food and Drug Administration (FDA) for potential emergency use of a new anthrax vaccine the company recently developed.

The vaccine, called NuThrax, is being developed as an anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis, or anthrax, exposure. It should be used in conjunction with the recommended course of antimicrobial therapy. NuThrax, also known as AV7909, 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, which is absorbed with the immunostimulatory oligodeoxynucleotide compound CPG 7909, is designed to elicit a faster immune response than currently available anthrax vaccines. It will have a two-dose schedule.

There have been several Phase 1 and Phase 2 clinical studies to investigate the safety, efficacy, and stability of NuThrax. The FDA submission package was completed via Emergent’s contract with the Biomedical Advanced Research and Development Authority (BARDA). That agreement includes a five-year base period of performance valued at approximately $200 million to develop NuThrax and to deliver to the Strategic National Stockpile an initial 3 million doses following pre-approval by FDA.

“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,” Jenkins said. “We look forward to NuThrax being an EUA-eligible product to enable deliveries to the Strategic National Stockpile in 2019.”

Emergent BioSolutions is a global life sciences company that focuses on providing specialty products that address accidental, intentional, and naturally occurring public health threats.