Key Takeaways
- Dupixent significantly reduces chronic obstructive pulmonary disease exacerbations by up to 34%.
- The drug improves lung function rapidly and sustains these improvements over 52 weeks.
- Dupixent is now a new option for COPD patients in China who are not adequately controlled by triple therapy.
- The approval follows similar regulatory endorsements in the EU and other countries.
China has taken a significant step in its battle against chronic obstructive pulmonary disease (COPD) with the National Medical Products Administration (NMPA) approving Dupixent (dupilumab), developed by Sanofi and Regeneron, as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. This approval marks a milestone for chronic obstructive pulmonary disease patients and their caregivers, offering a new treatment option aimed at alleviating the disease’s debilitating effects. The decision is based on positive outcomes from two landmark phase 3 studies, BOREAS and NOTUS, which demonstrated Dupixent’s efficacy in reducing exacerbations, improving lung function, and enhancing the overall quality of life for patients.
The BOREAS and NOTUS phase 3 studies, which were pivotal in securing Dupixent’s approval, specifically evaluated the drug’s effectiveness and safety among adults with uncontrolled COPD who had raised blood eosinophils. These patients were already receiving maximal standard-of-care inhaled therapies, including triple therapy. In the BOREAS study, Dupixent was shown to reduce chronic obstructive pulmonary disease exacerbations by 30%, while the NOTUS study revealed a 34% reduction in exacerbations compared to a placebo. Additionally, both studies highlighted rapid and sustained improvements in lung function over 52 weeks, accompanied by enhancements in health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ).
Dupixent’s Approval Fills Critical Gaps in Chronic Obstructive Pulmonary Disease Treatment
Professor Kang Jian, Chair of the COPD Branch at the Chinese Association of Chest Physicians, emphasized the severe burden chronic obstructive pulmonary disease places on both patients and their families. He underscored that Dupixent’s approval fills a critical gap in the available therapies for COPD, particularly for those patients who are inadequately controlled by existing treatments. He expressed hope that this new treatment option will provide much-needed relief for many individuals suffering from this chronic disease.
Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi, echoed Professor Jian’s sentiments. He pointed out the urgent need for more effective treatments in China, which has the world’s largest population of COPD patients. Ashrafian noted that the Dupixent chronic obstructive pulmonary disease clinical program has made significant contributions to the scientific understanding of COPD and its management, signaling a major advance in therapeutic approaches for the condition.
China Approves Dupixent as First Biologic for Chronic Obstructive Pulmonary Disease, Advancing Treatment Options
The approval of Dupixent as the first-ever biologic medicine for COPD in China is a groundbreaking development in the treatment landscape for this debilitating disease. The findings from the BOREAS and NOTUS studies provide robust evidence supporting its efficacy and safety, offering a novel therapeutic option for patients who are not well-managed by existing treatments. Moreover, the importance of public awareness and education on chronic obstructive pulmonary disease cannot be overstated, as the disease continues to impose a substantial health and economic burden in China.
By incorporating Dupixent into COPD treatment protocols, healthcare providers in China can potentially reduce the frequency of exacerbations, improve lung function, and enhance the quality of life for patients. This aligns closely with the goals of the Healthy China 2030 initiative, which seeks to promote public health and reduce the burden of chronic diseases across the nation. As such, the approval of Dupixent represents not only a significant medical advancement but also a critical step forward in China’s efforts to combat chronic obstructive pulmonary disease on a broader scale.
Resource: Sanofi, September 27, 2024
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