FDA Approves Dupixent for COPD

The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The decision was based on compelling evidence from two significant phase 3 clinical trials, BOREAS and NOTUS, which assessed the efficacy and safety of Dupixent compared to a placebo in adult patients who were already receiving the highest standard-of-care inhaled therapy, including nearly all participants on triple therapy. These individuals had COPD that remained inadequately managed and had blood eosinophil levels of at least 300 cells per μL.

The trials included 468 and 470 participants for Dupixent and 471 and 465 participants for the placebo, respectively. The results demonstrated that Dupixent led to a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over the course of 52 weeks, which was the primary endpoint, compared to the placebo. Moreover, there were greater improvements observed in postbronchodilator forced expiratory volume in the first second (FEV1) from baseline at week 12, with Dupixent showing improvements of 74 mL and 68 mL versus the placebo. These improvements were maintained at the 52-week mark.

The safety profile of Dupixent during the trials was generally in line with its known safety characteristics. However, it was noted that cholecystitis occurred in 0.6% of the patients on Dupixent, compared to 0.1% of the patients on the placebo.

George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron and a principal inventor of Dupixent, expressed optimism about the FDA's decision. He highlighted that this approval represents a significant advancement for the many COPD patients who struggle with breathing difficulties in their daily lives. Yancopoulos emphasized that Dupixent is a first-in-class medication that has already provided substantial benefits to patients suffering from various type 2 inflammatory diseases, including asthma and atopic dermatitis.

This newly approved indication for Dupixent was officially granted to Regeneron.