Dupixent Approved in China as First Biologic for COPD Patients
核心洞察
The NMPA in China approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled COPD (搜索) with raised blood eosinophils.
Landmark Phase 3 trials (BOREAS and NOTUS) demonstrated Dupixent significantly reduced COPD (搜索) exacerbations and improved lung function over 52 weeks.
Dupixent inhibits IL-4 (搜索) and IL-13 (搜索) pathways, addressing type-2 inflammation, and is administered via subcutaneous injection every other week.
The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD (搜索)) characterized by raised blood eosinophils. This approval marks a significant advancement in COPD treatment in China, where the disease is highly prevalent and a public health priority.
The approval specifically targets patients already using a combination of inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or a LABA and a LAMA if ICS is not suitable. Dupixent has already been approved for COPD (搜索) treatment in over 30 countries, including those in the EU.
Clinical Trial Data
The approval is based on the outcomes of the Phase 3 BOREAS and NOTUS studies. These studies evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled COPD (搜索) and elevated blood eosinophils, all of whom were on maximal standard-of-care inhaled therapy. The results demonstrated that Dupixent significantly reduced COPD exacerbations by 30% and 34% compared to placebo in the BOREAS and NOTUS studies, respectively. Furthermore, Dupixent rapidly improved lung function, with these improvements sustained over 52 weeks. The St. George’s Respiratory Questionnaire (SGRQ) also revealed improvements in health-related quality of life compared to placebo, with statistically significant results in BOREAS and nominally significant results in NOTUS. The data from both studies were published in The New England Journal of Medicine.
Safety Profile
The safety profile of Dupixent in these studies was consistent with its known safety profile across approved indications. Common side effects included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia (搜索). Additional adverse reactions reported in the COPD (搜索) studies included injection site bruising, induration, rash, and dermatitis. Adverse events observed more frequently with Dupixent (≥5%) compared to placebo included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Impact on COPD Treatment in China
"The impact of COPD (搜索) extends far beyond the patient," said Professor Kang Jian, Chair of COPD Branch, Chinese Association of Chest Physicians, CMDA, Respiratory Department of First Hospital of China Medical University. "Debilitating breathlessness and irreversible lung damage make it difficult for patients to do simple daily tasks, placing a significant burden on family members, the central caregivers in Chinese families. The approval of Dupixent for COPD in China is critical, as it fills a gap in targeted therapy for the disease and provides clinicians with a new treatment approach, offering new hope for COPD patients who remain inadequately controlled even after triple therapy, as well as those who care for them."
Mechanism of Action
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4 (搜索)) and interleukin-13 (搜索) (IL-13 (搜索)) pathways. It is administered via subcutaneous injection every other week and is not an immunosuppressant. The drug's development program has demonstrated significant clinical benefits and a decrease in type-2 inflammation in Phase 3 studies, confirming that IL-4 and IL-13 are key drivers of type-2 inflammation in multiple related diseases.
Future Development
Sanofi and Regeneron are jointly developing dupilumab under a global collaboration agreement. Currently, dupilumab is being studied in Phase 3 trials for a range of diseases driven by type-2 inflammation or other allergic processes, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses are under clinical investigation, with their safety and efficacy yet to be fully evaluated by regulatory authorities.
Additional submissions for Dupixent in COPD (搜索) are under review with regulatory authorities around the world, including in the US and Japan.