The European Medicines Agency (EMA) has granted approval to Sanofi and Regeneron's blockbuster biologic Dupixent (dupilumab) as the first-ever targeted therapy in the EU for adults with uncontrolled chronic obstructive pulmonary disease (COPD) marked by raised blood eosinophils.
The EU approval is based on two landmark phase 3 studies demonstrating significant reductions in exacerbations, improved lung function, and enhanced health-related quality of life for patients. The EMA's decision makes Dupixent the first new treatment approach for COPD in over a decade, offering a new option for approximately 220,000 adults in the European Union.
Dupixent's approval is specifically for patients who are already on a combination of inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on LABA and LAMA if ICS is not suitable. The phase 3 BOREAS and NOTUS studies, which supported the approval, showed that patients treated with Dupixent experienced a 30-34% reduction in annual moderate or severe COPD exacerbations and significant improvements in lung function and quality of life.
The approval marks the sixth indication for Dupixent in the EU and the seventh globally. With additional regulatory submissions under review in the U.S., China, Japan, and other countries, Dupixent's approval in the EU could pave the way for broader global access.
In the U.S., the FDA delayed the review for a label expansion of Dupixent in COPD back in May. According to Sanofi, the agency had requested additional efficacy analyses from the BOREAS and NOTUS pivotal trials, which were submitted in May. The agency determined this information constituted a major amendment to the sBLA, extending the PDUFA date to September 27, 2024.
Also in May, Sanofi presented data from the phase 3 NOTUS study at the 2024 American Thoracic Society International Conference, confirming the positive results from the phase 3 BOREAS study. Sanofi and Regeneron remain confident that the additional analyses support the approval of Dupixent in COPD and are committed to working with the FDA.
Now a top seller for both Sanofi and Regeneron, Dupixent was first approved in 2017 for eczema. It has since received subsequent approvals in asthma, rhinosinusitis, prurigo nodularis and eosinophilic esophagitis, including pediatric approvals in eczema and eosinophilic esophagitis.
