Dupixent, a biologic medicine developed by Sanofi and Regeneron, has been approved by the Health Sciences Authority (HSA) in Singapore as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). This approval follows similar endorsements in the EU, US, and China, and is based on two phase 3 studies demonstrating significant reductions in exacerbations and improvements in lung function and quality of life compared to placebo.
The approval marks a significant milestone as Dupixent is the first biologic medicine available for COPD patients in Singapore. COPD, a progressive lung disease, affects approximately 6% of the population and is a leading cause of death. Weeling Quek, Head of Immunology at Sanofi Southeast Asia and India, stated, “With the Singapore approval of Dupixent for COPD, we are not just launching a new indication; we are igniting a beacon of hope for countless individuals.”
The phase 3 studies, BOREAS and NOTUS, involved 1,874 patients and showed a 30% and 34% reduction in the annualised rate of moderate or severe COPD exacerbations over 52 weeks, respectively. Additionally, patients experienced rapid improvements in lung function and health-related quality of life. Safety results were consistent with Dupixent’s known profile, with common adverse events including viral infections and headaches.
This approval is part of Sanofi and Regeneron’s broader effort to transform COPD treatment by targeting inflammation pathways. Dupixent’s approval in Singapore offers new hope for patients with this debilitating disease, potentially improving their quality of life and reducing hospitalisations.
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