Dupixent® Approved in EU as First Targeted Therapy for COPD

Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the European Commission (EC) has granted approval for Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. This approval, based on the significant results from two pivotal Phase 3 trials, marks Dupixent as the first new treatment approach for COPD in more than ten years, offering a new option for approximately 220,000 adults in the European Union (EU). This approval extends Dupixent's indications to six in the EU and seven globally.

The two landmark Phase 3 trials leading to this approval, named BOREAS and NOTUS, were published in the New England Journal of Medicine. They assessed Dupixent's efficacy and safety in adults suffering from uncontrolled COPD with signs of type 2 inflammation, indicated by blood eosinophils of 300 cells per µL or greater. The trials involved patients who were already on standard inhaled therapy, including nearly all on triple therapy. Both trials demonstrated that Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life compared to placebo.

Specifically, patients on Dupixent in the BOREAS and NOTUS trials experienced substantial reductions in exacerbations and notable improvements in lung function. These benefits were consistent across various subgroups, including different smoking statuses and baseline lung functions. Safety findings in these trials were in line with the known safety profile of Dupixent, with common side effects including injection site reactions, conjunctivitis, and eosinophilia. Additional adverse events reported in the COPD trials included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Dupixent's approval is a significant milestone for patients with uncontrolled COPD, who have had limited treatment options for over a decade. The addition of Dupixent, a first-in-class biologic targeting the underlying cause of COPD, represents a new era in the management of this debilitating disease. The approval is particularly welcomed by patient advocacy groups, as it provides hope for better disease management and improved quality of life.

The BOREAS and NOTUS trials enrolled a total of 1,874 patients, aged between 40 to 85 years, who were current or former smokers with moderate-to-severe COPD. The primary endpoint of the trials was the annualized rate of moderate or severe COPD exacerbations, with secondary endpoints including changes in lung function and health-related quality of life. Patients received Dupixent or placebo every two weeks, in addition to their maximal standard-of-care inhaled therapies.

Dupixent works by inhibiting the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, which are central to type 2 inflammation. This mechanism has demonstrated significant clinical benefits across multiple diseases driven by type 2 inflammation, including asthma and atopic dermatitis. With regulatory approvals in over 60 countries, Dupixent is now used by more than 900,000 patients worldwide for various indications.

The development program for Dupixent is a collaborative effort between Regeneron and Sanofi, aimed at addressing a broad range of diseases driven by type 2 inflammation. This approval for COPD further solidifies Dupixent's role in transforming the treatment landscape for chronic inflammatory diseases, offering new hope and improved outcomes for patients suffering from these debilitating conditions.

Regeneron and Sanofi continue to explore the potential of Dupixent and other innovative treatments in their pipeline to provide life-changing solutions for patients worldwide. The companies are committed to advancing the understanding of COPD and other inflammatory diseases through rigorous clinical research and development efforts.