On Jul. 3, 2024, Regeneron Pharmaceuticals and Sanofi announced that the European Commission (EC) has approved Dupixent^® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The EC is the first regulatory authority in the world to approve Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities around the world, including in the U.S., China and Japan.

The approval is based on results from the landmark Phase 3 BOREAS and NOTUS trials, which were separately published in the New England Journal of Medicine and evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy (with nearly all on triple therapy).

Reductions in exacerbations and improvements in lung function for Dupixent versus placebo were also observed in patients with higher baseline fractional exhaled nitric oxide (FeNO; ≥20ppb) – an airway biomarker of inflammation – and across all pre-defined subgroups including smoking status, baseline lung function and history of exacerbations.

Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo in either COPD trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis. Additional adverse reactions of injection site bruising, injection site induration, injection site rash and injection site dermatitis were reported in the COPD trials.

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.