FDA OKs Dupixent for Certain Patients with Asthma

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.

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