French drug major Sanofi (SNYNF,SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that Dupixent (dupilumab) has been recommended for European Union approval to treat patients with chronic obstructive pulmonary disease or COPD.
The European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending the approval of Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils.
If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade.
The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
COPD, a respiratory disease, damages the lungs and causes progressive lung function decline. Dupixent, which is being jointly developed by Sanofi and Regeneron, is a fully human monoclonal antibody and its development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies.
The companies noted that the positive CHMP opinion is supported by data from the landmark BOREAS and NOTUS phase 3 studies that evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation. The primary endpoint was met in both studies, showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo.
Sanofi and Regeneron noted that the use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.
The companies' submissions are also under review with regulatory authorities around the world, including in the U.S. and China.
The U.S. Food and Drug Administration earlier this year accepted for Priority Review the supplemental Biologics License Application for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD. The target action date is September 27.
In more than 60 countries, Dupixent has received regulatory approvals for indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU) in different age populations.
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