The approval is based on data from a phase 3 placebo-controlled trial that evaluated the efficacy and safety of dupilumab combined with standard-of-care therapy in children with uncontrolled moderate-to-severe asthma.
The FDA has approved dupilumab (Dupixent, Regeneron Pharmaceuticals Inc, Sanofi) as an additional maintenance treatment of patients between 6 and 11 years of age with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, according to a Regeneron press release.
"Despite available treatments, moderate-to-severe asthma can severely impact children's developing airways, causing sleepless nights, persistent coughing and wheezing, and potentially life-threatening exacerbations that require the use of systemic steroids that can negatively affect growth," said George D. Yancopoulos, MD, PhD, president and CSO at Regeneron, in a press 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 US. In our pivotal trial, Dupixent helped children aged 6 to 11 years breathe better, suffer fewer asthma attacks and improve health-related quality of life. We also continue to study Dupixent in patients with other dermatologic, respiratory and gastrointestinal conditions where type 2 inflammation may play a role."
The approval is based on data from a phase 3 placebo-controlled trial that evaluated the efficacy and safety of dupilumab combined with standard-of-care therapy in children with uncontrolled moderate-to-severe asthma. More than 90% of children in the trial had at least 1 concurrent type 2 inflammatory condition.
The study found that among patients who entered the trial with high levels of a certain type of white blood cell, the addition of dupilumab to standard-of-care decreased the rate of severe asthma attacks with a 65% average reduction over 1 year compared to placebo; improved lung function after as early as 2 weeks and maintained up to 52 weeks as measured by a percent predicted pre-bronchodilator FEV1; and improved asthma control at 24 weeks with 81% of patients showing a clinically meaningful improvement based on disease symptoms and impact compared to 64% of patients in the placebo group.
Further, the overall rates of adverse events (AEs) were 83% for dupilumab and 80% for placebo. The most frequent AEs observed were injection site reactions, viral upper respiratory tract infections, and eosinophilia.
FDA Expands Approval of Dupixent® (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma. PR Newswire. October 20, 2021. Accessed October 21, 2021. https://www.prnewswire.com/news-releases/fda-expands-approval-of-dupixent-dupilumab-to-include-children-aged-6-to-11-years-with-moderate-to-severe-asthma-301405141.html