FDA Approves Asthma Indication for Dupixent

The FDA has approved dupilumab (Dupixent, Regeneron and Sanofi) in patients with moderate-to-severe asthma aged 12 years and older.

The medication’s new approval indicates it’s use as an add-on maintenance therapy with an eosinophilic phenotype or with oral corticosteroid-dependent asthma, according to Regeneron and Sanofi.

Dupilumab inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), 2 key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).

According to George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, Dupixent has now been approved by the FDA for 2 important groups of uncontrolled asthma patients— those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma.

"In the asthma clinical trial program, Dupixent reduced severe exacerbations and oral corticosteroid use, improved quality of life and showed statistically significant and clinically meaningful improvements in lung function,” said Yancopoulos, in a prepared statement.

Efficacy and safety of dupilumab in patients with moderate-to-severe asthma aged 12 years and older was determined through a pivotal trial program that evaluated 2,888 adult and adolescent patients with moderate-to-severe asthma. These patients were studied in 3 randomized, placebo-controlled, multicenter trials (Trial 1, Trial 2 and Trial 3) for 6 months to 1 year (24 to 52 weeks). All trials enrolled patients irrespective of minimum baseline eosinophil levels.

In Trial 2 (the largest trial), dupilumab reduced exacerbations and improved lung function in the overall population. Benefits in exacerbations were seen in patients with eosinophil counts greater than or equal to 150 cells/microliter, which represented 70% of the patients enrolled. Efficacy improved in patients with higher eosinophil counts. For example, in patients with blood eosinophils of 300 cells/microliter or greater, dupilumab reduced severe exacerbations by 67% compared to placebo, and improved FEV₁ (lung function) by 29%-33% compared to 14%-16% for placebo. In patients with eosinophil counts less than 150 cells/microliter, there was no difference in severe exacerbation rates for dupilumab versus placebo.

In Trial 3, which evaluated severe, oral corticosteroid-dependent patients, dupilumab reduced average daily oral corticosteroid use by 70% compared to 42% with placebo. More than half of patients treated with dupilumab completely eliminated use of oral corticosteroids. Effects on lung function and on oral steroid and exacerbation reduction were similar for dupilumab irrespective of baseline blood eosinophil levels.

In the asthma clinical trials, the adverse reactions that occurred with dupilumab at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood.

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