FDA Accepts Dupilumab sBLA for Asthma Add-on Therapy

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) of dupilumab (DUPIXENT) as an add-on maintenance therapy for adults and adolescents aged 12 years or older with moderate-to-severe asthma.

DUPIXENT, the product of Regeneron Pharmaceuticals and Sanofi, has been given a PDUFA action date of October 20, 2018.

The human monoclonal antibody functions as an inhibitor of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, limiting the proteins from their contribution to Type 2 inflammation in patients with moderate-to-severe asthma.

The companies’ application to the FDA included clinical data from 3 pivotal trials in their development program LIBERTY ASTHMA. The program tested the overall effect of dupilumab in 2888 adults and adolescents with asthma — 1902 of whom participated in LIBERTY ASTHMA.

Results of the study, as shared in September 2017, reported that comparable results for both 200 mg and 300 mg DUPIXENT were found in the regimen’s treatment of asthma exacerbations and forced expiratory volume over 1 second (FEV1).

At 52 weeks of treatment, patients receiving 300 mg dupilumab reported a reduction of severe asthma attacks by a mean 46% in the overall population. Sixty percent of patients with 150 eosinophilic cells/mL, and 67% of patients with at least 300 eosinophilic cells/mL reported severe asthma attack reduction (P < 0.001).

At 12 weeks, mean improvement in lung function for the 300 mg dupilumab patient group versus placebo as expressed by FEV1 was 130 mL (9%) in the overall population, 150 mL (11%) in patients with 150 eosinophilic cells/mL or greater, and 240 mL (18%) in patients with 300 eosinophilic cells/mL or greater (P < 0.001).

At the time of the study’s results, George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, expressed optimism for the companies’ targeted efforts in allergic condition therapy.

“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,” Yancopoulos said in a statement.

Data results from the phase 3 QUEST and VENTURE trials, which were submitted in the DUPIXENT sBLA in conjunction with LIBERTY ASTHMA QUEST, will be submitted for presentation at medical meetings later this year.

Last year, the FDA approved DUPIXENT in the US for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is not properly controlled with topical therapies. The antibody is also approved for use in particular patients with atopic dermatitis in other regions of the world, including the European Union, Canada, and Japan.

Dupilumab is being investigated in phase 2 and 3 trials by Sanofi and Regeneron for pediatric atopic dermatitis, nasal polyps, and eosinophilic esophagitis.

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