Sanofi-Regeneron Dupixent recommended for EU approval by CHMP to treat COPD patients

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 3 studies that 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 (nearly all on triple therapy). The primary endpoint was met in both studies, 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 studies were generally consistent with the known safety profile of Dupixent in its approved indications.

Submissions are also under review with regulatory authorities around the world, including in the U.S. and China. Earlier this year, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD. The target action date is September 27, 2024.

The use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU) in different age populations. More than 850,000 patients are being treated with Dupixent globally.