Dupixent (dupilumab) sBLA is accepted for FDA priority review for treatment of COPD with type 2 inflammation.- Regeneron + Sanofi

The target action date for the FDA decision is June 27, 2024. Regulatory submissions are under review in China and Europe.

The sBLA, as well as other submissions around the world, is supported by data from the Phase III 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 (i.e., blood eosinophils greater than 300 cells per ?L). 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 annualized moderate or severe acute COPD exacerbations by 30% and 34%, respectively, compared to placebo. In both trials, Dupixent 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 ( greater than 5%) compared to placebo in either trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis. 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.