Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

Dupixent, a drug from Sanofi and Regeneron Pharmaceuticals, is now approved in Europe for adults with uncontrolled chronic obstructive pulmonary disorder (COPD) characterized by elevated blood eosinophils. COPD patients often require multiple medications to manage the chronic condition. The new approval allows Dupixent to be used as an add-on maintenance treatment for those whose COPD remains uncontrolled by available therapies, or for whom inhaled corticosteroids are unsuitable.

Unlike some anti-inflammatory drugs, Dupixent does not suppress the immune system. Instead, it is an antibody that blocks IL-4 and IL-13, signaling proteins in pathways associated with inflammation. Since its initial approval in 2017 for atopic dermatitis, Dupixent has been approved for various immunological conditions, including asthma. Despite its success in asthma, there were uncertainties about its effectiveness in COPD, as other biologics had failed in this disease.

Sanofi’s Paul Rowe highlighted that previous attempts by AstraZeneca and GSK to treat COPD with biologics had failed, casting doubts on Dupixent's potential. However, the recent EMA approval marks a significant milestone, providing a new treatment option for COPD patients with eosinophilic inflammation, just before the U.S. Independence Day holiday.

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