The second phase 3 trial for Dupixent (dupilumab) showed the drug was able to reduce exacerbations by 34%, confirming positive results from earlier trials.
Regeneron Pharmaceuticals and Sanofi released the results in late 2023 and said the trial also showed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks. In addition, those improvements were sustained at 52 weeks.
The trial evaluated the use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. Regeneron submitted the data from this trial, along with positive results from an earlier trial to the U.S. Food and Drug Administration for consideration.
Earlier in 2023, the FDA granted breakthrough therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype.
The trial included 935 adults who were current or former smokers aged 40 to 85 years and randomized to receive either Dupixent or placebo. The results were consistent with previously announced results from an earlier trial, which showed a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks and improved lung function at 12 weeks.
In addition to the FDA, the European Medicines Agency is also reviewing Regeneron and Sanofi’s application for Dupixent for the treatment of uncontrolled COPD with type 2 inflammation.
