Dupixent Approved in China as First Biologic for COPD

Dupixent, a biologic medicine, has been approved in China for the treatment of adults with chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. This approval by the National Medical Products Administration (NMPA) makes Dupixent the first biologic treatment available for COPD patients in China. The decision comes after similar approvals in the European Union, based on significant findings from two important phase 3 studies.

COPD is the most common chronic respiratory disease in China and is a significant focus of the country's Healthy China 2030 public health initiative. The approval of Dupixent is a critical step in addressing the healthcare needs of millions of COPD patients in the country. Dupixent is now approved in China for four indications including respiratory and dermatological diseases.

The treatment is intended for patients currently managing their COPD with a combination of inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), and long-acting muscarinic antagonist (LAMA). If ICS is not suitable, a combination of LABA and LAMA can be used. Dupixent has also been approved for COPD treatment in over 30 countries worldwide, including all 27 EU member states.

Professor Kang Jian, Chair of the COPD Branch at the Chinese Association of Chest Physicians, noted that COPD deeply affects patients' quality of life, making everyday tasks challenging and placing a burden on their families. He emphasized that Dupixent's approval fills a crucial gap in COPD treatment, offering a new option for patients who are not adequately managed with existing therapies.

Houman Ashrafian, MD, PhD, Executive Vice President and Head of Research and Development at Sanofi, highlighted the urgent need for effective treatments in China, home to the largest number of COPD patients globally. Current therapies often fail to control the disease, leaving patients desperate for new options. Dupixent's strong safety and efficacy profile provides new hope for these patients.

The approval in China is based on data from the BOREAS and NOTUS phase 3 clinical trials. These studies demonstrated that Dupixent significantly reduced COPD exacerbations by 30% and 34% respectively compared to placebo. Additionally, the treatment improved lung function and health-related quality of life, with improvements sustained over 52 weeks. Findings from these studies were published in The New England Journal of Medicine.

Safety data from the trials indicated that common side effects of Dupixent included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Specific to COPD studies, additional side effects like injection site bruising and dermatitis were reported. More frequently observed adverse events included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, remarked that the approval of Dupixent is a significant advancement for the millions of COPD patients in China. He pointed out the increasing global risk for COPD, especially in industrialized regions, and stressed the importance of delivering innovative treatment options.

Sanofi and Regeneron are also pursuing additional regulatory approvals for Dupixent in COPD, including in the US and Japan. Their collaborative research program is exploring the role of type-2 inflammation in COPD progression. Besides Dupixent, the program is also investigating itepekimab, another potential biologic treatment currently in phase 3 clinical trials.

Dupixent is currently available in China as a 300 mg pre-filled syringe or pen and is administered via subcutaneous injection every other week. The treatment can be self-administered at home following training by a healthcare professional. With regulatory approvals in over 60 countries, Dupixent is used to treat various conditions, including asthma, atopic dermatitis, and now COPD.

This collaborative development effort by Sanofi and Regeneron aims to broaden the scope of Dupixent's application to other chronic diseases driven by type-2 inflammation, potentially offering new treatment avenues for a wide range of conditions.