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 with moderate to severe asthma characterized by an eosinophilic phenotype or oral corticosteroid-dependent asthma.

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

In this trial, children with an eosinophil count of 300 cells / µL or greater who received 100 mg or 200 mg of dupilumab given by subcutaneous injection every 2 weeks, compared to standard care, had a level of reduced asthma exacerbations over 1 year (0.24 events vs. 0.67 events); 2-week improvement in lung function, which continued up to 52 weeks; and improved asthma control at 24 weeks (81% vs. 64%). In children with an elevated FeNO of 20 ppb or greater, dupilumab also reduced the rate of severe exacerbations. The safety results were consistent with the known safety profile of dupilumab in patients aged 12 and older with uncontrolled asthma, the statement said.

“This approval means that Dupixent, a unique treatment with a well-established efficacy and safety profile, can now be used by young children with certain types of moderate to severe asthma in the United States. George D. Yancopoulos, MD, PhD, President and Scientific Director of Regeneron Pharmaceuticals, said in the press release. “Dupixent has helped children aged 6 to 11 breathe easier, suffer fewer asthma attacks and improve their health-related quality of life. “

“This FDA approval brings new hope for children who may suffer 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 statement.

In the United States, Dupixent is approved as an adjunct maintenance therapy in patients 6 years of age and older with moderate to severe asthma characterized by an eosinophilic phenotype or OCS-dependent asthma; in patients aged 6 years and older with moderate to severe uncontrolled atopic dermatitis; and for use with other drugs for the maintenance treatment of chronic rhinosinusitis with nasal polyps in adults whose disease is not under control, the release said.