FX.co ★ Sanofi, Regeneron: Dupixent Recommended For EU Approval By CHMP To Treat COPD Patients

Sanofi (SNYNF, SNY) and Regeneron Pharmaceuticals, Inc. (REGN) jointly announced that their drug Dupixent (dupilumab) has received a recommendation for approval by the European Union to treat patients suffering from chronic obstructive pulmonary disease (COPD).

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion, endorsing Dupixent as an additional maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils.

If approved, Dupixent would become the first targeted therapy for COPD available within the EU, marking the first innovative treatment for this ailment in over ten years.

The European Commission is anticipated to make a final decision on Dupixent's application within the coming months.

COPD is a chronic respiratory disease that leads to progressive lung damage and decline in lung function. Dupixent, a fully human monoclonal antibody, is being co-developed by Sanofi and Regeneron. The drug has shown substantial clinical benefits and a reduction in type 2 inflammation in phase 3 clinical trials.

The endorsement from CHMP is grounded in data from the pivotal BOREAS and NOTUS phase 3 studies, which assessed the efficacy and safety of Dupixent in adults with uncontrolled COPD demonstrating type 2 inflammation. Both studies met their primary endpoints, evidencing that Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to a placebo.

Sanofi and Regeneron emphasized that Dupixent's usage in COPD is still investigative and pending approval from global regulatory bodies.

The drug's applications are under evaluation by regulatory authorities worldwide, including the United States and China.

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted a Priority Review for the supplemental Biologics License Application for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD, with a target action date set for September 27.

Currently, Dupixent holds regulatory approvals in over 60 countries for multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU) across various age groups.

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