Dupixent application accepted for priority review by USFDA for COPD with type 2 inflammation

The sBLA, as well as other submissions around the world, is supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation (screening blood eosinophils >300 cells/microliter). All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy). The primary endpoint was met in both trials (BOREAS, NOTUS), showing Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% respectively, compared to placebo. In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.

Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo in either trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis.

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Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in COPD is currently under clinical development, and its safety and efficacy for this indication have not been fully evaluated by any regulatory authority.

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.