Dupilumab for asthma in USDecember 13, 2018
The US Food and Drug Administration has approved dupilumab (Dupixent) as an add-on maintenance therapy in patients aged 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype and those with oral corticosteroid-dependent asthma.
Dupilumab inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two 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).
The pivotal trial programme evaluated 2,888 adult and adolescent patients with moderate-to-severe asthma in three randomized, placebo-controlled, multicentre trials for six months to one year.
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.
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 the use of oral corticosteroids, announced Regeneron Pharmaceuticals, Inc and Sanofi.