FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma and EGPA

Fasenra is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa). It binds to the alpha subunit of the IL-5 receptor, which is expressed on eosinophils and basophils, leading to antibody-dependent cell-mediated cytotoxicity, reducing eosinophil levels.

Fasenra is indicated for: - Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. - Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.

Administer by subcutaneous injection. Asthma: - Adults and adolescents (12 years and older): 30 mg every 4 weeks for first 3 doses, then every 8 weeks. - Pediatric patients 6 to 11 years: weight-based dosing. Less than 35 kg: 10 mg every 4 weeks for first 3 doses, then every 8 weeks. 35 kg or more: 30 mg every 4 weeks for first 3 doses, then every 8 weeks. EGPA: - 30 mg every 4 weeks. General: Warm to room temperature for about 30 minutes before use. Visually inspect for particulate matter and discoloration. Do not use if cloudy, discolored, or contains large particles. Inject into thigh, abdomen, or upper arm (if given by healthcare provider or caregiver). Prefilled syringe for healthcare provider use; autoinjector (Fasenra PEN) for patient/caregiver use after training. For asthma patients aged 6 to 11 years weighing 35 kg or more, Fasenra PEN should only be administered by caregiver or healthcare provider.

Trial data not available in label.

Not reported in label.

Fasenra is an add-on maintenance therapy for severe eosinophilic asthma and a treatment for EGPA. It is not for acute bronchospasm or status asthmaticus. Monitoring after administration is recommended.