Following recent approvals in the EU, US and China, the Singapore approval is based on two replicate phase 3 studies that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo.
The Health Sciences Authority (HSA) has approved Dupixent (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterized 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. The prevalence of COPD is estimated to be around 6% of the general population[1], and it ranks as a leading cause of death[2].
Weeling Quek
Head of Immunology at Sanofi, Southeast Asia & India
"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. This milestone underscores our commitment towards patients battling this debilitating disease. We are dedicated to transforming the lives of patients, giving them the chance to reclaim precious moments with their loved ones, and experience a life with fewer limitations."
The FDA approval is based on data from two phase 3 studies (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with inadequately controlled COPD and blood eosinophils ≥300 cells per μL. Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):
30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
Rapid improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.
51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks, as assessed by a 4-point improvement on the St. George's Respiratory Questionnaire (SGRQ).
Safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled BOREAS and NOTUS data, the most common adverse events (>2%) more frequently observed in patients on Dupixent compared to placebo were viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache and gastritis. While less common, cholecystitis was reported in 0.6% of patients on Dupixent compared to 0.1% of patients on placebo.
About COPD
COPD is a respiratory disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety, and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid medicine and/or antibiotics. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still have progressive lung disease.
About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy. In the US, approximately 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype. Patients with an eosinop...
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