FDA Accepts Dupilumab sBLA for Treatment of 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.

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.

For more information, go to SpecialtyPharmacyTimes.com