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New Indication Alert: Singapore Approves Dupixent® (Dupilumab) for COPD

May 14, 2025

On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.  Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

In Singapore, Dupixent® is the first biologic medicine approved to treat these COPD patients and follows approval of the same indication in Japan in March 2025.

Dupixent® was also approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.  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.

Dupixent® was also recently approved by the US FDA for Chronic Spontaneous Urticaria (CSU) in  April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.