The FDA has approved Sanofi and Regeneron Pharmaceuticals' Dupixent as the first biologic medicine for adults with chronic obstructive pulmonary disease (COPD).
The treatment is specifically for patients with an eosinophilic phenotype whose COPD remains inadequately controlled despite standard therapies. This approval follows similar decisions in the European Union and China.
Dupixent's approval is based on two phase 3 clinical studies that demonstrated the drug's ability to significantly reduce COPD exacerbations. Patients treated with Dupixent also showed improvements in lung function and overall quality of life compared to those on a placebo. The drug is expected to offer relief to around 300,000 adults in the U.S. living with this form of COPD.
The introduction of Dupixent is a major milestone in the treatment of COPD. While most COPD therapies focus on inhalers and other standard treatments, Dupixent offers a new option for patients who experience severe exacerbations and impaired lung function despite those efforts.
In May, the FDA delayed its decision on expanding the use of Dupixent for COPD treatment, following a request for additional efficacy analyses from the pivotal BOREAS and NOTUS trials. Sanofi submitted the required data in May, and the FDA classified this as a major amendment to the application, pushing the decision date to September 27, 2024.
Around the same time, Sanofi shared findings from the phase 3 NOTUS study at the 2024 American Thoracic Society International Conference, reinforcing the positive results from the earlier BOREAS trial. Both Sanofi and Regeneron are confident that the supplemental data will support Dupixent's approval for COPD.
Originally approved in 2017 for eczema, Dupixent has since become a key product for Sanofi and Regeneron, with further approvals in asthma, rhinosinusitis, prurigo nodularis, eosinophilic esophagitis, and pediatric uses for eczema and eosinophilic esophagitis.