Fasenra Approved for Pediatric Patients With Severe Eosinophilic Asthma

The Food and Drug Administration (FDA) has expanded the approval of Fasenra (benralizumab) for add-on maintenance treatment of severe asthma to include patients aged 6 to 11 years with an eosinophilic phenotype. Previously, the treatment had only been approved for patients 12 years and older.

The approval was supported by evidence from trials involving adult and adolescent patients, as well as findings from the 48-week TATE study (ClinicalTrials.gov Identifier: NCT04305405), which evaluated the pharmacokinetics, pharmacodynamics, and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, in children aged 6 to 11 years (N=28). At baseline, median blood eosinophil levels were 400 cells/µL in patients weighing less than 35kg and 340 cells/µL in those weighing 35kg or more.

Findings showed a subcutaneous (SC) dose of 10mg (patients <35kg) or 30mg (patients ≥35kg) of benralizumab administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter was determined to have similar or higher exposure, respectively, to adults and adolescents administered an SC dose of 30mg with the same dosing regimen. Across all time points after benralizumab administration, median eosinophil counts reduced to 10 to 20 cells/µL in patients weighing less than 35kg, and to 20 to 30 cells/µL in patients weighing 35kg or more.

With regard to safety, no new signals were identified in the trial and safety for the higher drug exposure was supported by data from previous adult and adolescent trials in patients who received 30mg every 4 weeks for 1 year. The most common adverse reactions associated with treatment include headache and pharyngitis.

Fasenra is supplied as a 10mg/0.5mL and 30mg/mL solution in a single-dose prefilled syringe, and a 30mg/mL solution in a single-dose autoinjector (Fasenra Pen). For patients 6 to 11 years old, the dosage of Fasenra is based on body weight (<35kg: 10mg; ≥35kg: 30mg) and is administered every 4 weeks for the first 3 doses followed by once every 8 weeks thereafter.