Sanofi SA has announced the results of its phase 3 studies evaluating itepekimab for the treatment of chronic obstructive pulmonary disease (COPD) in former smokers. The AERIFY-1 study met its primary endpoint by demonstrating a statistically significant reduction in moderate or severe exacerbations, offering a clinically meaningful benefit. However, the AERIFY-2 study did not meet its primary endpoint despite showing some benefits earlier in the trial. Itepekimab was generally well tolerated in both studies, with comparable rates of adverse events between the treatment and placebo groups. Sanofi, in collaboration with Regeneron, is currently assessing the data and plans to discuss the results with regulatory authorities to determine the next steps. Additionally, itepekimab is being evaluated for other conditions, including chronic rhinosinusitis with and without nasal polyps, and bronchiectasis.
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