FDA Grants Approval to Emergent’s Anthrax Vaccine Cyfendus After 4 Years of Supplying the Shot

FDA Approves Emergent’s Cyfendus, an Anthrax Vaccine with 4 Years of Supply History

Source – Emergent BioSolutons

Emergent BioSolutions has been delivering its AV7909 anthrax vaccine to the Department of Health and Human Services under a pre-emergency use authorization since 2019, as part of the emergency preparedness for a potential anthrax attack. Now, the company has secured a full approval from the FDA for its vaccine, which is marketed as Cyfendus, for adults 18 to 65 who may have been exposed to the deadly bacteria and need to take antibacterial drugs.

Cyfendus is a vaccine that combines anthrax vaccine adsorbed (AVA) and an adjuvant. It can induce a protective immune response with two doses given over 14 days.

The approval boosted Emergent’s stock price by 8% from Thursday’s close. Emergent has faced a lot of challenges in the past few years, after failing to deliver on its contracts to produce COVID-19 vaccines and losing most of its share value. The company’s CEO Robert Kramer, who was instrumental in Emergent’s growth, resigned last month.

“The approval of Cyfendus vaccine is symbolic of Emergent’s long standing partnership with the US government and our shared commitment to helping protect public health. The 20-year journey from early development to approval is a major milestone that attests to Emergent’s scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

– Dr. Kelly Warfield, Emergent’s senior vice president, science and development

Cyfendus has not been tested on humans, but it showed positive results in animal studies. It also demonstrated its lot consistency, immunogenicity and safety in a Phase III trial that used a two-dose schedule given intramuscularly, Emergent said.

A Phase II study also showed that Cyfendus did not interfere with antibacterial drugs. Cyfendus is Emergent’s second anthrax vaccine, after BioThrax, which the company supplied to the Strategic National Stockpile in two five-year contracts worth $1.25 billion and $1.5 billion respectively. Emergent also has two anthrax treatments in its portfolio—Anthrasil, a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody.

“Cyfendus vaccine is a component of the U.S. government’s preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact. The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the US government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine.”

– Paul Williams, Emergent’s senior vice president, products business

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