Emergent BioSolutions receives U.S. FDA Approval of Cyfendus, previously known as AV7909
The U.S. Food and Drug Administration has approved Cyfendus, a vaccine for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis (anthrax) in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.
Cyfendus vaccine is comprised of Anthrax Vaccine Adsorbed (AVA) and an additional adjuvant. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, which can be especially important in response to a large-scale public health emergency involving anthrax. In December 2018, Cyfendus vaccine was the subject of a pre-emergency use authorization package submitted to the FDA. The following year, the U.S. government began procuring this product for national preparedness efforts.
The FDA approval of Cyfendus vaccine is based on data from a series of studies supported by the U.S. government and conducted by Emergent, including: a pivotal Phase 3 clinical study that evaluated the lot consistency, immunogenicity, and safety of the vaccine following a two-dose schedule administered intramuscularly in healthy adults; and a Phase 2 study that evaluated non-interference between the vaccine and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease.
Emergent’s anthrax franchise also includes the BioThrax vaccine, which will continue to serve a critical purpose, as well as two treatments, Anthrasil, a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.
The Biologics License Application submission and attainment of product licensure were completed under contract number HHSO100201600030C for the advanced development and delivery of Cyfendus vaccine, funded by BARDA, within the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services. Early-stage development funding was also provided by NIAID, part of the National Institutes of Health, and DARPA of the U.S. Department of Defense.
Information on Cyfendus may be found on FDA’s website.