FDA Expands Dupilumab to Moderate to Severe Pediatric Asthma


The indication makes 6 to 11-year-old children with eosinophilic biomarkers or corticosteroid dependency eligible for the biologic add-on therapy.

FDA Approves Dupilumab for Moderate to Severe Pediatric Asthma

The US Food and Drug Administration (FDA) has expanded the approval of dupilumab (Dupixent) to include children aged 6 to 11 years old with moderate to severe asthma.

The newest indication for the interleukin 4 and 13 (IL-4; IL-13) inhibitor from Regeneron and Sanofi approves its use as an add-on maintenance therapy among children with eosinophilic-phenotype asthma or those with a dependency on oral corticosteroids.

Dupilumab’s benefit for such use was based on findings from the LIBERTY ASTHMA VOYAGE study, a phase 3, randomized, double-blind, controlled trial assessing the monoclonal antibody’s efficacy and safety combined with standard care versus lone standard care in children with uncontrolled moderate to severe asthma.

Their trial population included 408 children, of whom more than 90% had ≥1 concurrent type 2 inflammatory disease.

Patients who had ≥300 eosinophil cells/mcl at baseline (n = 259) treated with 100 mg or 200 mg Dupilumab every 2 weeks reported a 65% mean reduction in severe asthma attacks over 1 year versus lone standard care (0.24 vs 0.67 events per year).

Lung function, per percent predicted forced expiratory volume at 1 second (FEV1pp) prior to bronchodilator use, was also significantly improved in Dupilumab-treated patients: treated patients reported a mean 5.32 percentage-point reduction versus control patients.

The observed safety profile in LIBERTY ASTHMA VOYAGE patients was consistent to that reported in moderate to severe asthma patients aged ≥12 years treated with dupilumab in previous trials. Adverse events were reported in 83% of treated patients, versus 80% of control patients. Common adverse events among the dupilumab-treated included injection site reactions (18%), viral upper respiratory tract infections (12%), and eosinophilia (6%).

In a statement accompanying the approval, Naimish Patel, MD, Head of Sanofi’s Global Development in Immunology and Inflammation, said the newest indication for dupilumab “brings new hope for children” suffering from severe asthma attacks and poor lung function.

“Dupixent has helped to make a difference to the lives of many patients and families across three diseases with underlying type 2 inflammation, with more than 300,000 patients treated globally,” Patel said. “We now have the opportunity to offer a safe and effective treatment option to children as young as 6 years of age living with certain types of moderate-to-severe asthma."

In a recent HCPLive Lungcast interview with American Lung Association Chief Medical Officer Al Rizzo, MD, Mario Castro, MD, MPH, University of Kansa School of Medicine Chief of Pulmonary, Critical Care and Sleep Medicine, described “the exciting time” being experienced in asthma biologic therapy development.

Though no current biologic therapies indicated for treating asthma—primarily dupilumab and omalizumab—are not defined as disease-modifying by the FDA, there is potential for agents to achieve such distinction.

“They are achieving control, they are improving lung function, and we think that they might have a chance at disease modification,” Castro said. “I’m looking toward improving lung function and normalizing patients’ disease to the point where they do not have progressive disability from it.”

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