FDA Approves Dupilumab for Children with Moderate-to-Severe Asthma

By Adam Hochron, Staff Writer

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The FDA has approved dupilumab as a maintenance add-on treatment for children aged 6 and 11 with moderate-to-severe asthma, according to a release from the manufacturer. 

The approval is based on results from a phase 3 trial evaluating the safety and efficacy of dupilumab with standard-of-care asthma treatment. Among patients with high levels of eosinophils (≥300 cells/μl; n=259), those who were treated with either 100 mg or 200 mg dupilumab every 2weeks reported a 65% reduction in the rate of severe asthma attacks over 1 year compared with placebo (0.24 events per year vs. 0.67).

The young patients also reported improved lung function as early as 2 weeks after treatment with sustained effects for up to 52 weeks. The release also noted that after 12 weeks, patients in the drug arm reported a 5.32% increase in their lung function. In addition, after 24 weeks, 81% of patients in the drug arm reported clinically meaningful improvement in their asthma symptoms compared with 64% of patients treated with placebo. 

“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,” said Naimish Patel, MD, Head of Global Development in immunology and Inflammation at Sanofi, in the release. “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.”

The safety profile reported during the trial was similar to those in patients age 12 and over with uncontrolled moderate-to-severe asthma. One notable addition was the reporting of helminth infections in 2.2% of patients in the dupilumab arm, compared to 0.7% of patients in the placebo group. Overall, 83% of patients in the dupilumab arm reported an adverse event, compared to 80% for placebo patients. The most commonly reported adverse events included injection site reactions, viral upper respiratory tract infections, and eosinophilia.  

The release noted that dupilumab is being studied as a potential treatment for other conditions, including COPD with evidence of type 2 inflammation, pediatric atopic dermatitis, and eosinophilic esophagitis. 


Photo Credit: Getty Images

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