Benralizumab is now approved by the US Food and Drug Administration for the treatment of asthma in children older than 6 years.
Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older. The drug is approved as a maintenance add-on for patients with severe eosinophilic asthma.
AstraZeneca, which markets the drug, announced the approval for younger patients on April 11.
The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said.
For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh
The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.
Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
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