FDA approves FASENRA (benralizumab) for severe asthma in children aged 6-11.
FDA approves FASENRA (benralizumab) for the treatment of severe asthma in children aged 6-11 with an eosinophilic phenotype. Benralizumab, a monoclonal antibody, was initially approved in 2017 for patients aged 12 and older. The FDA's decision was supported by the TATE study, which demonstrated the drug's pharmacokinetics, pharmacodynamics, and safety in children aged 6-11.
April 11, 2024
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