CHMP recommends Dupixent ((dupilumab) to treat uncontrolled chronic obstructive pulmonary disease (COPD)

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

COPD is a respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. There have been no new treatment approaches approved for more than a decade.

The positive CHMP opinion is supported by data from the landmark BOREAS and NOTUS Phase III trials that evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation (i.e., blood eosinophils greater than 300 cells per uL).All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy). The primary endpoint was met in both trials, showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo. Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.

Additionally, Dupixent improved health-related quality of life at 52 weeks (statistically significant in BOREAS and nominally significant in NOTUS) as assessed by the St. George’s Respiratory Questionnaire (SGRQ). 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.