Dupixent, a monoclonal antibody already used to treat several other conditions, has received approval from the European Union as a novel treatment for uncontrolled COPD, commonly known as smoker's bronchitis. This marks a major breakthrough in the management of COPD, as it is the first targeted therapy approved for this condition in over a decade.
The approval is based on positive results from two Phase 3 clinical trials, which demonstrated that Dupixent, when added to standard therapy, significantly reduced moderate to severe acute exacerbations of COPD. While not a cure, Dupixent offers a promising new treatment option for patients struggling with the debilitating symptoms of COPD, such as chronic cough, shortness of breath, and breathing difficulties.
The authorisation specifically targets a subset of patients with uncontrolled COPD who have a specific inflammatory profile. In Europe alone, this represents over 220,000 individuals who could potentially benefit from this new treatment. Sanofi has already applied for early access authorization in France, with the aim of making the treatment available to a limited number of patients by the end of the year.
Dupixent, a flagship product for Sanofi, has proven to be a commercial success, generating significant revenue for the company. This latest approval for COPD adds to its growing list of indications and is expected to further bolster Sanofi's financial performance. In 2023, Dupixent contributed €10.7 billion to the pharmaceutical group's revenue, accounting for nearly a quarter of its total sales.
