A Phase 3 study of dupilumab met its two primary endpoints, reducing severe exacerbations and improving lung function in asthma patients, when added to standard therapies, according to Regeneron Pharmaceuticals and Sanofi.
According to a company press release, at 52 weeks, in the 300 mg dose group, dupilumab reduced severe asthma attacks by 46% in the overall population, 60% in patients with 150 eosinophilic cells/microliter or greater, and 67% in patients with 300 eosinophilic cells/microliter or greater (p less than 0.001 for all groups).
At 12 weeks, in the 300 mg dupilumab dose group, mean improvement in lung function over placebo as assessed by FEV1 was 130 mL (9%) in the overall population, 150 mL (11%) in patients with 150 eosinophilic cells/microliter or greater, and 240 mL (18%) in patients with 300 eosinophilic cells/microliter or greater (p less than 0.001 for all groups).
The companies plan to submit a Supplemental Biologics License Application (sBLA) to the US FDA by the end of this year.
“Approximately one million US adults and adolescents live with uncontrolled, persistent asthma, and continue to experience serious asthma attacks, despite taking an intensive regimen of standard therapies,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron. “Dupilumab has now demonstrated positive late-stage results in two serious allergic diseases — asthma and atopic dermatitis — with robust efficacy and an extensive safety database. These results continue to support our hypothesis that the IL-4/IL-13 pathway is a critical driver of allergic disease, and we remain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases.”
In March 2017, the FDA approved Dupixent (dupilumab) in the US for the treatment of moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies.