Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbationsin pivotal trial 

• First and only biologic to demonstrate clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo
• First and only biologic to show rapid and significant improvement in lung function (160 mL in FEV1) compared to placebo (77 mL in FEV1)
• First and only biologic to demonstrate significant improvements in quality of life and respiratory symptoms
• COPD is the third leading cause of death worldwide with no new treatment approaches approved in more than a decade; trial enrolled patients with moderate to severe disease and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells/μL)
• COPD is the seventh disease in which Dupixent has shown positive pivotal results, confirming the key role of IL-4 and IL-13 in these type 2 inflammatory diseases

Paris and Tarrytown, N.Y.March 23, 2023. The primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms.

Dietmar Berger, M.D., Ph.D.Head of Global R&D ad interim and Chief Medical Officer at Sanofi"Change cannot come quick enough for people living with uncontrolled COPD but,unfortunately,many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limitedtreatment options. We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines. We are excited to share these unprecedentedand potentially paradigm-shifting clinical results, which may give new hope to patients, caregivers and physicians.”

COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. 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 or even death. Smoking is a key risk factor for COPD, but even individuals who quit smoking can still develop the disease. In the U.S. alone, approximately 300,000 people live with uncontrolled COPD with type 2 inflammation.

George D. Yancopoulos, M.D., Ph.D.President and Chief Scientific Officer at Regeneron“COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no noveltreatments approved in more than a decade.In this landmark Phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. These results also validate the role type 2 inflammation plays in driving COPDin these patients, advancing the scientific community’s understanding of the underlying biology of this disease. We look forward to discussing these exciting results with regulatory authorities.”

In the BOREAS Phase 3 trial (the first of two Phase 3 trials), 939 adults who were current or former smokers aged 40 to 80 years were randomized to receive Dupixent (n=468) or placebo (n=471), added to maximal standard-of-care inhaled therapy. Patients receiving Dupixent experienced:

• 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
• Improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo (p