Dupixent approved in EU as targeted therapy for COPD: Sanofi, Regeneron Pharma

Paul Hudson, Chief Executive Officer at Sanofi said, “Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function. With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils. We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries.”

The approval is based on results from the landmark phase 3 BOREAS and NOTUS studies, 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). In terms of efficacy, Dupixent patients in BOREAS (n=468) and NOTUS (n=470) experienced the following, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):

• 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
• Improvements in lung function (pre-bronchodilator FEV₁) from baseline by 160 mL and 139 mL at 12 weeks compared to 77 mL and 57 mL. These improvements were observed as early as week 2 and 4 and were sustained at 52 weeks in both studies.
• Improvements in health-related quality of life (statistically significant in BOREAS and nominally significant in NOTUS), as assessed by the St. George’s Respiratory Questionnaire.

Reductions in exacerbations and improvements in lung function for Dupixent versus placebo were also observed in patients with higher baseline fractional exhaled nitric oxide (≥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 studies 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.G

eorge D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron, said, “The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalization, irreversible health decline and feelings of hopelessness. With this approval, we are proud that Dupixent has the potential to redefine the treatment landscape in yet another disease, as a first-in-class therapy demonstrating unprecedented improvements on exacerbations and lung function, as well as improving health-related quality of life across two large phase 3 trials.”

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