AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug Administration (FDA) for its anti-eosinophil biologic Fasenra (benralizumab). The drug is now approved as an add-on maintenance treatment for severe asthma in pediatric patients aged 6 to 11 years with an eosinophilic phenotype, expanding its original indication for severe eosinophilic asthma (SEA) in individuals aged 12 and older.
This approval was supported by data from a late-stage trial that successfully met its primary endpoints, demonstrating comparable pharmacokinetics (PK) and pharmacodynamics (PD) to earlier studies. Additionally, the safety and tolerability profiles of the subcutaneous injection were found to be consistent with previous findings.- Flcube.com
