FDA nod for Emergent BioSolutions' Cyfendus

The US Food and Drug Administration (FDA) has approved Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, developed by US biotech Emergent BioSolutions (NYSE: EBS), whose shares closed up 8% on the news.

The vaccine is authorized for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of Cyfendus vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

Under a pre-emergency use authorization, Emergent BioSolutons has provided the Department of Health and Human Services with its AV7909 anthrax vaccine for emergency preparedness since 2019.