FDA Accepts sBLA of Dupilumab for Asthma

Sanofi recently announced that the FDA has accepted the supplemental Biologics License Application (sBLA) of dupilumab (Dupixent) for the maintenance treatment of asthma, according to a press release.

Sanofi is seeking approval for dupilumab as an add-on therapy for adults and adolescents with moderate-to-severe asthma.

The PDUFA date for this indication is October 20, 2018, according to the release.

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Dupilumab is a human monoclonal antibody designed to inhibit interleukin-4 and interleukin-13 cytokines, which are known to contribute to asthma-related inflammation. These patients typically experience type 2 allergic inflammation, which is characterized by an imbalance of immune cells and other proteins.

Patients with moderate-to-severe asthma typically experience exacerbations that may result in emergency department visits and hospitalizations, according to Sanofi. There is currently an unmet need for patients with asthma who experience decreased lung function, severe attacks, long-term corticosteroid use, and poor quality of life, according to the release.

The new sBLA was the result of positive findings from 3 clinical trials from the LIBERTY ASTHMA drug development program, which included 2888 adults and adolescents with moderate-to-severe asthma.

Sanofi plans to submit findings from the phase 3 QUEST and VENTURE clinical trials to medical meetings in 2018, according to the release.

Dupilumab is currently under clinical development for asthma, meaning that the safety and efficacy in this patient population has not been evaluated by regulatory authorities.

The FDA previously approved dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who did not respond or were intolerant to topical treatments. Dupilumab is approved for this indication in the European Union, Canada, and Japan, according to the release.