The European Commission has approved dupilumab (Regeneron and Sanofi) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This approval is the first of its kind globally and provides a new treatment option for approximately 220,000 adults in the European Union. This marks the sixth indication for dupilumab in the EU and the seventh globally.
The approval was based on results from the Phase 3 BOREAS and NOTUS trials, which included over 900 patients each. These studies evaluated dupilumab in patients with moderate-to-severe COPD who were already on maximal standard-of-care inhaled therapy. The trials demonstrated that dupilumab significantly reduced exacerbations by 30% and 34% respectively and improved lung function from baseline by 160 mL and 139 mL compared to 77 mL and 57 mL with placebo. Improvements in health-related quality of life were also noted, assessed by the St. George’s Respiratory Questionnaire.
Safety profiles in both trials were consistent with dupilumab’s known safety profile, with common adverse events including injection site reactions, conjunctivitis, back pain, and nasopharyngitis. The therapy, administered subcutaneously every two weeks, targets type 2 inflammation, which is implicated in COPD-related lung inflammation and symptoms.
“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.” commented George D Yancopoulos, Board Co-chair, President, and Chief Scientific Officer at Regeneron in a press release regarding the approval.
This approval represents a significant advancement in COPD treatment, offering new hope for patients with this challenging condition. Further regulatory reviews are ongoing in the U.S., China and Japan.
Disclosures: This article was created by the touchRESPIRATORY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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