Emergent BioSolutions Says FDA Accepts AV7909 Anthrax Vaccine Candidate BLA For Review

RTTNews | 1140 hari yang lalu
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Emergent BioSolutions Says FDA Accepts AV7909 Anthrax Vaccine Candidate BLA For Review

(RTTNews) - Emergent BioSolutions Inc. (EBS) announced Friday that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).

AV7909 is the company's new anthrax vaccine candidate evaluated 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 Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

The rolling BLA submission, completed in April 2022, is based on data from the pivotal phase 3 clinical study of AV7909 that evaluated the lot consistency, immunogenicity, and safety of the vaccine candidate following a two-dose schedule administered intramuscularly in healthy adults.

It also included data from the phase 2 study that evaluated non-interference between AV7909 and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease.

Teg: EBS
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