FDA approves dupilumab for children aged 6 to 11 with moderate to severe asthma

The FDA has approved dupilumab as an add-on maintenance treatment for children aged 6 to 11 years with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

The expanded approval of dupilumab (Dupixent, Regeneron/Sanofi) to children aged 6 to 11 was based on data from the phase 3, double-blind, placebo-controlled LIBERTY ASTHMA VOYAGE trial that evaluated efficacy and safety of dupilumab compared with standard care in children with uncontrolled moderate to severe asthma. More than 90% of children in the trial had at least one concurrent type 2 inflammatory condition, according to a company press release.

“I was impressed that dupilumab met not only its primary endpoint of reduction in asthma exacerbations, but also all key secondary endpoints in the pediatric ASTHMA VOYAGE trial,” Leonard B. Bacharier, MD, professor of pediatrics at Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center and principal investigator of the ASTHMA LIBERTY VOYAGE trial, told Healio. “I anticipate that clinicians will begin to include dupilumab in their discussions with families of children with uncontrolled moderate-severe asthma. Many children in this age group continue to experience repeated asthma exacerbations, and experience side effects from frequent courses of systemic corticosteroids. Dupilumab’s demonstrated efficacy in significantly reducing exacerbations will allow such children greater disease control.”

In that trial, children with an eosinophil count of 300 cells/µL or higher who were assigned dupilumab 100 mg or 200 mg delivered by subcutaneous injection every 2 weeks, compared with standard care, had a reduced rate of asthma exacerbations over 1 year (0.24 events vs. 0.67 events); improved lung function by 2 weeks, which continued for up to 52 weeks; and improved asthma control by 24 weeks (81% vs. 64%). In children with elevated FeNO of 20 ppb or higher, dupilumab also reduced the rate of severe exacerbations. Safety results were consistent with the known safety profile of dupilumab in patients aged 12 years and older with uncontrolled asthma with the addition of helminth infections, according to the release.

“This approval means that Dupixent, a first-of-its-kind treatment with a well-established efficacy and safety profile, can now be used by younger children with certain types of moderate to severe asthma in the U.S.,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron Pharmaceuticals, said in the release. “Dupixent helped children aged 6 to 11 years breathe better, suffer fewer asthma attacks and improve health-related quality of life.”

“This FDA approval brings new hope for children who may be suffering from life-threatening asthma attacks and poor lung function, affecting their ability to breathe, potentially into adulthood,” Namish Patel, MD, head of global development in immunology and inflammation at Sanofi, said in the release.

In the United States, Dupixent is approved as an add-on maintenance treatment of patients aged 6 years and older with moderate to severe asthma characterized by an eosinophilic phenotype or with OCS-dependent asthma; in patients aged 6 years and older with uncontrolled moderate to severe atopic dermatitis; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled, according to the release.