Regeneron, Sanofi report Dupixent reduced COPD exacerbations in second trial

Regeneron (REGN) and Sanofi (SNY) announced that the second Dupixent investigational Phase 3 chronic obstructive pulmonary disease, or COPD, trial, or NOTUS, showed that Dupixent significantly reduced exacerbations, confirming results from the Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. The NOTUS trial evaluated the investigational 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. These results were from an interim analysis and, given the efficacy of the primary endpoint, will be considered the primary analysis of the trial. Regeneron and Sanofi plan to submit the data from this replicate trial, along with results from the Phase 3 BOREAS trial to the FDA by the end of the year.