Sanofi's Dupixent approved in US as first biologic for COPD patients

Sanofi Secures FDA Approval for Dupixent in COPD Treatment

New York/Paris – September 27, 2024 – Sanofi announced today that its Dupixent (dupilumab) medication has received approval from the U.S. Food and Drug Administration (FDA). This approval marks Dupixent as the first biologic medicine authorized for adults in the United States suffering from inadequately controlled chronic obstructive pulmonary disease (COPD) who also exhibit an eosinophilic phenotype. The decision is expected to benefit approximately 300,000 patients in the U.S.

The FDA's decision was informed by data from two pivotal Phase 3 trials, BOreAS and NOTUS. These studies evaluated the efficacy and safety of Dupixent when added to maximal standard-of-care inhaled therapy, compared to a placebo. The trials demonstrated that Dupixent significantly reduced the annual rate of moderate or severe COPD exacerbations over a 52-week period. Furthermore, patients treated with Dupixent experienced improvements in lung function and health-related quality of life compared to those receiving placebo.

Dupixent is already utilized by one million patients globally across various conditions driven by type 2 inflammation. Sanofi's Chief Executive Officer, Paul Hudson, stated that the approval allows patients to look forward to potentially improved breathing and fewer exacerbations. The company highlighted that Dupixent has previously revolutionized treatment paradigms for several diseases with high unmet medical needs.

Safety data from the trials indicated that the most common adverse events associated with Dupixent were consistent with its known safety profile in other approved indications. These included viral infections and headaches. A slightly higher incidence of cholecystitis was observed in patients receiving Dupixent compared to placebo.