Sanofi and Regeneron share results from phase 3 trial for Dupixent as COPD treatment
Betsy Goodfellow | November 27, 2023 | News story | Medical Communications | COPD, Cardiology, Dupixent, Sanofi, clinical trial
Sanofi and Regeneron have announced results from the second investigational phase 3 NOTUS trial for Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), demonstrating that the drug reduced exacerbations by 34% and confirming results from the phase 3 BOREAS trial.
The trial also demonstrated that treatment with the drug led to rapid and significant improvements in lung function after 12 weeks with these improvements maintained at the 52-week point.
The trial assessed Dupixent as a treatment for adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPT and evidence of type 2 inflammation, compared to placebo.
It is expected that Sanofi and Regeneron will submit this data alongside data from the previous phase 3 BOREAS trial to the US Food and Drug Administration (FDA) by the end of 2023.
Naimish Patel MD, head of global development, immunology and inflammation, at Sanofi, commented: “This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two phase 3 trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade. These data validate our belief that Dupixent has the potential to transform the treatment of moderate-to-severe COPD and given the significant unmet needs for patients with uncontrolled COPD, we are not stopping with Dupixent. Our second programme in COPD, itepekimab, continues with data expected in 2025. If positive, Dupixent and itepekimab could emerge as treatments for approximately 80% of those suffering from moderate-to-severe COPD with recurrent exacerbations.”
Betsy Goodfellow
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