FDA Approves Dupilumab as ‘Add-on’ for Moderate-to-severe Asthma Patients

The U.S. Food & Drug Administration (FDA) has approved dupilumab “as an add-on maintenance treatment” for patients aged 12 years and older with moderate-to-severe asthma “with an eosinophilic phenotype or with oral corticosteroid dependent asthma,” according to the FDA’s product label. 

Dupilumab, marketed as Dupixent, is manufactured by Sanofi and Regeneron Pharmaceuticals. The FDA recommends that, in the treatment of asthma, it is injected at an initial dose of 400 mg (two 200-mg injections) followed by 200 mg every two weeks, or at an initial dose of 600 mg (two 300-mg injections) followed by 300 mg every two weeks. 

The FDA’s approval follows three randomized, placebo-controlled, multicenter trials including a total of 2,888 adult and adolescent moderate-to-severe asthma patients. Results from the largest trial, the second one, were published in the New England Journal of Medicine. Uncontrolled asthma patients (n = 1,902, age ≥ 12 years) were randomly assigned in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every two weeks or matched-volume placebos for 52 weeks. The 200 mg dupilumab group had a 47.7% lower annualized rate of severe asthma exacerbations than the matched-volume placebo group, with similar results observed in the 300 mg groups. At 12 weeks, the 200 mg dupilumab group had a 0.32-liter increase in forced expiratory volume in 1 second (difference vs. matched placebo, 0.14 liters; P < 0.001); the higher dose group had similar outcomes. For patients with a blood eosinophil count ≥ 300/cubic mm, the annualized severe asthma exacerbations rate in the 200 mg dupilumab group was 0.37 (95% CI, 0.29 to 0.48), compared with 1.08 (95% CI, 0.85 to 1.38) for the matched-volume placebo group (65.8% lower rate with dupilumab than with placebo; 95% CI, 52.0 to 75.6). The 300 mg dose groups yielded similar outcomes. 

The FDA previously approved dupilumab to treat adults with moderate-to-severe atopic dermatitis. According to the FDA, among asthma patients, the most frequent adverse reactions (incidence ≥ 1%) are injection site reactions, oropharyngeal pain, and eosinophilia. 

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Sources: Medscape, NEJMFDA