The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for Dupixent for priority review.
Regeneron Pharmaceuticals and Sanofi said in a joint news release that this would position Dupixent as an add-on maintenance treatment in certain adults with uncontrolled COPD. The target action date for the FDA’s decision is June 27, 2024. Similar submissions are also under review in China and the European Union.
The company said its application is supported by data from the phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who are current or former smokers and who have uncontrolled COPD with type to inflammation.
The primary endpoint was met in both trials conducted by the companies, with Dupixent significantly reducing moderate or severe acute COPD exacerbations by 30% to 34% compared to placebo. The improvements were sustained at 52 weeks.
The company said safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent compared to placebo were back pain, diarrhea, headache and nasopharyngitis.
