Emergent BioSolutions' Two-Dose Anthrax Vaccine Secures FDA Nod; Shares Jump

The FDA approved Emergent BioSolutions Inc's EBS anthrax vaccine for adults aged 18 through 65.

The vaccine Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, is approved for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis when administered in conjunction with recommended antibacterial drugs. 

Also Read: FDA Approves First OTC Naloxone Nasal Spray For Opioid Overdose.

The efficacy of the Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

It has been demonstrated that using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response.

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.

In addition to the Cyfendus vaccine, Emergent's anthrax franchise includes the BioThrax vaccine, as well as two treatments, Anthrasil [Anthrax Immune Globulin Intravenous (human)], a polyclonal antibody therapeutic, and raxibacumab, a monoclonal antibody therapeutic.

Emergent has been delivering Cyfendus to the U.S. Department of Health and Human Services since 2019 under pre-emergency use authorization status and will continue to work with the U.S. government to transition to post-approval procurement, the company said.

Price Action: EBS shares are up 17.28% at $8.28 during the premarket session on the last check Friday.