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Regeneron Pharmaceuticals and Sanofi have announced positive results from their phase 3 trial, titled NOTUS, evaluating Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD). The trial demonstrated that Dupixent significantly reduced COPD exacerbations by 34% (compared to placebo) in patients with moderate-to-severe COPD who also show evidence of type 2 inflammation of the lungs. These findings confirm the results from the previously completed BOREAS trial.
We are highlighting the results of this study to acknowledge the contributions of JoinAStudy.ca Investigator Dr. Syed Anees and his clinic patients, whose dedication to this study have been an important factor in establishing the necessary data to reach the results established by the NOTUS trial. He was also a participant in an earlier study of dupilumab and its effects on exercise capacity in adult patients with asthma (R668-AS-1903).
Approximately 300,000 people in the United States suffer from uncontrolled COPD with evidence of type 2 inflammation, and no new treatment options have been approved for over a decade. Given the promising results from both NOTUS and BOREAS trials, Regeneron and Sanofi plan to submit data to the U.S. Food and Drug Administration (FDA) by the end of the year for potential approval. Earlier in the year, the FDA granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD.
These findings represent a significant advancement in COPD treatment, with Dupixent potentially becoming the first approved biologic for this serious respiratory disease. The companies are also exploring another biologic, itepekimab, for COPD treatment, with data expected in 2025. The positive results from the NOTUS trial provide hope for transforming the treatment paradigm for moderate-to-severe COPD patients who have experienced recurrent exacerbations, addressing a critical unmet medical need.
To read the full press release from Regeneron, please click here.
For a brief, more technical summary of these study results, please click here.