FDA Updates Week of April 8: Fasenra Gets New Indication

Fasenra Approved for Children with Severe Asthma

The FDA has approved AstraZeneca’s Fasenra (benralizumab) as an add-on maintenance treatment for children aged 6 to 11 with eosinophilic asthma. Fasenra was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in patients aged 12 and older.

Eosinophilic asthma is a rare type of asthma where white blood cells called eosinophils are elevated, causing inflammation. Fasenra is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils and leads to depletion of blood and tissue eosinophils.

This additional indication was supported by evidence from TATE, an open-label, phase 3 trial, as well as trials in adult and adolescent populations. In the TATE study, Fasenra met the primary endpoints, demonstrating pharmacokinetics and pharmacodynamics in the younger patient population that were consistent with those seen in prior trials.

The recommended dose is 30 mg for patients 6 years and older who weigh 35 kg or more. For patients aged 6 to 11 who weigh less than 35 kg, a new 10 mg dose will be available. Fasenra is administered by subcutaneous injection every four weeks for the first three doses, and then every eight weeks.

The list price for Fasenra is $5,511.41 per 30 mg dose. AstraZeneca says for people with employer or individual private insurance, the average out-of-pocket cost is $46 per dose. Some patients may pay as little as $0 for Fasenra and as little as $0 for its injection administration. For people with Medicare Advantage plans, the average out-of-pocket cost is $90 per dose