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New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in UK for COPD

Sep 12, 2024

On 12 September 2024, PM Live reported that Sanofi and Regeneron’s Dupixent® (dupilumab) has been approved by the UK Medicines Healthcare products Regulatory Agency (MHRA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).

This follows an announcement by the companies the previous day that a confirmatory phase 3 study of Dupixent® met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.  In the same month, Sanofi reported that Q2 2024 Dupixent® sales grew by 29.2% to over €3.3B.