FDA Expands Approval of Severe Asthma Drug

The FDA expanded the approval of benralizumab (Fasenra) to include treatment of younger kids with uncontrolled severe asthma with an eosinophilic phenotype, AstraZeneca announced on Thursday.

Previously approved for individuals 12 and up, the broader indication now allows for use of the injectable add-on maintenance therapy in patients ages 6 to 11 years as well.

Pharmacokinetic and pharmacodynamic data from the TATE trial supported the expanded approval. The non-randomized phase III study included 28 patients ages 6 to 11 years with severe eosinophilic asthma and met its primary endpoints (maximum serum concentration, clearance, half-life, and blood eosinophil count), showing that treatment with benralizumab in this younger age group was consistent with treatment in adolescents and adults. Across doses (10 mg/30 mg) and weight groups (<35 kg/≥35 kg), benralizumab induced near-complete depletion of blood eosinophils.

About half of patients with severe asthma have elevated circulating levels of eosinophils, a type of white blood cell. Patients with this phenotype have decreased lung function, an increased risk for exacerbations, and are often reliant on oral glucocorticoids to manage symptoms.

A monoclonal antibody directed against the alpha subunit of the interleukin-5 (IL-5) receptor, benralizumab works by binding to the IL-5 receptor on eosinophils and inducing apoptosis through antibody-dependent cell-mediated cytotoxicity.

Prior trials involving individuals 12 and older with severe eosinophilic asthma demonstrated up to a 51% reduction in the annual exacerbation rate with benralizumab versus placebo, along with improvements in lung function (as measured by forced expiratory volume in one second) and significant reductions in the need for corticosteroids.

“We welcome additional treatment options for children living with severe asthma, a condition that remains complicated to manage, further helping to address the unmet need in this patient population and reducing the burden of disease for the broader asthma community,” Lynda Mitchell, CEO of the Allergy & Asthma Network, said in a statement from the drugmaker.

The most common adverse reactions observed with benralizumab include headaches and pharyngitis, seen in 5% or more of the population treated with the drug. In trials, pain at the injection site was present in 2.2% of benralizumab-treated patients and 1.9% of placebo patients.

The safety profile of benralizumab in the TATE trial was similar to previous studies in adolescents and adults, with adverse events occurring in 78.6% of participants — none of which resulted in discontinuation or death.

Labeling for benralizumab warns that hypersensitivity reactions have happened after administration, warns against abrupt reductions or discontinuations of corticosteroids after starting the drug, and recommends treating pre-existing parasitic (helminth) infections before staring benralizumab or to halt treatment until a parasitic infection resolves.

The treatment is administered subcutaneously in 4-week intervals for the first three doses, then every 8 weeks thereafter. A new 10-mg dose is now available for kids ages 6 to 11 years who weigh below 35 kg; for individuals ages 6 years and older who weigh 35 kg or more, the originally approved 30-mg dose is recommended.

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