Sanofi Korea said on Friday that its atopic dermatitis drug Dupixent (dupilumab) has expanded its indication to include add-on maintenance therapy for adults with chronic obstructive pulmonary disease (COPD) who have an elevated blood eosinophil count and are not adequately controlled by standard inhaled therapy.
(Credit: Sanofi Korea)
(Credit: Sanofi Korea)
COPD is characterized by shortness of breath, fatigue, and acute exacerbations, which can significantly reduce patients' quality of life and even lead to death.
Despite the availability of inhaler-based three-drug combo therapies, about 50 percent of patients still experience severe exacerbations, highlighting an unmet need.
As “the first and only approved targeted biologic for COPD,” Dupixent is expected to offer new clinical benefits for patients whose condition remains uncontrolled by existing therapies, Sanofi Korea said.
In two phase 3 studies, Dupixent reduced the annualized exacerbation rate of COPD and significantly improved lung function and patient quality of life. In the BOREAS and NOTUS phase 3 studies, which formed the basis for the indication expansion, moderate-to-severe annualized exacerbation rates of 0.78 and 0.86 for Dupixent at week 52 were 30 percent and 34 percent lower, respectively, than placebo rates of 1.1 and 1.3, meeting the primary efficacy endpoint.
Improvements in lung function occurred rapidly from week 2 of treatment with Dupixent and were maintained through week 52. In the BOREAS and NOTUS studies, forced expiratory volume in one second (FEV1) before bronchodilator use was 160 and 139 mL, respectively, compared to 77 and 57 mL, respectively, in the placebo group at week 12, and 153 and 115 mL, respectively, compared to 70 and 54 mL, respectively, at week 52.
The proportion of patients with at least a 4-point improvement in the St. George's Respiratory Questionnaire (SGRQ) was 51.5 percent and 51.4 percent in the Dupixent arm, compared to 43 percent and 47 percent in the placebo arm.
“COPD is a disease with a high burden due to acute exacerbations and declining lung function that remains uncontrolled by existing therapies, resulting in a significant unmet need for treatment,” said Bae Kyung-eun, General Manager Pharma Multi-Country Office South Korea and Austrailia/New Zealand & MCO Lead. “Additionally, under-diagnosis prevents patients who need treatment from receiving appropriate care. As the first and only approved targeted biologic for COPD, Dupixent represents a new paradigm in COPD treatment. We hope this approval will enable more people with COPD to receive appropriate treatment and improve their symptoms and quality of life.”
Dupixent is an immunomodulator that selectively blocks type 2 inflammation, unlike broad-spectrum immunosuppressants. It targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) cytokines, which are key drivers of type 2 inflammation. IL-4 and IL-13 are known to be critical factors in type 2 inflammation, a major cause of conditions such as COPD, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and nodular pruritic rash.
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Kim Yoon-mi yoonmi@docdocdoc.co.kr
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