FDA Approves First COPD Biologic

The FDA has granted approval for Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, as the first biologic treatment for adults suffering from chronic obstructive pulmonary disease (COPD). This new medication is intended specifically for patients who have an eosinophilic phenotype and whose COPD symptoms persist despite the use of conventional therapies. This U.S. approval follows previous approvals in the European Union and China.

Dupixent’s approval is supported by data from two phase 3 clinical trials that highlighted the drug’s efficacy in significantly reducing COPD exacerbations. Patients administered Dupixent experienced not only fewer exacerbations but also improved lung function and enhanced overall quality of life when compared to those given a placebo. It is anticipated that approximately 300,000 adults in the U.S. who suffer from this form of COPD will benefit from this innovative treatment.

The introduction of Dupixent represents a significant advancement in COPD management. While traditional COPD treatments largely rely on inhalers and other standard medications, Dupixent provides a new and potent option for patients who continue to have severe exacerbations and diminished lung function despite these existing treatments.

In May, the FDA postponed its decision regarding the expanded use of Dupixent for COPD treatment after requesting additional efficacy data from the BOREAS and NOTUS pivotal trials. Sanofi subsequently submitted the necessary data, which the FDA deemed a major amendment to the application, resulting in the decision being deferred to September 27, 2024.

Coinciding with this, Sanofi presented findings from the phase 3 NOTUS study at the 2024 American Thoracic Society International Conference. These findings bolstered the positive outcomes observed in the earlier BOREAS trial. Both Sanofi and Regeneron are optimistic that the supplementary data will further validate Dupixent’s use in treating COPD.

Initially approved in 2017 for eczema, Dupixent has since become a cornerstone product for Sanofi and Regeneron. Over the years, it has received additional approvals for a range of conditions, including asthma, rhinosinusitis, prurigo nodularis, eosinophilic esophagitis, and pediatric uses for eczema and eosinophilic esophagitis.