EMA Approves Dupixent for COPD

The European Medicines Agency (EMA) has granted approval to Sanofi and Regeneron's biologic drug Dupixent (dupilumab) as the first targeted therapy in the European Union (EU) for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils.

This approval comes on the heels of two landmark phase 3 studies, BOREAS and NOTUS, which demonstrated substantial benefits for patients. These studies showed that Dupixent significantly reduces exacerbations, enhances lung function, and improves the quality of life for individuals with this severe form of COPD. The EMA's decision marks the first new treatment option for COPD in over a decade, offering a new therapeutic avenue for approximately 220,000 adults within the EU.

Dupixent is approved for patients already on a regimen that includes inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or those on LABA and LAMA if ICS is unsuitable. The phase 3 trials demonstrated that patients treated with Dupixent experienced a 30-34% reduction in annual moderate or severe COPD exacerbations, along with significant lung function improvements and enhanced quality of life.

This recent approval is the sixth indication for Dupixent in the EU and the seventh globally. Additional regulatory submissions are under review in several other regions, including the United States, China, and Japan. The EU approval could potentially facilitate broader global access to this treatment.

In the United States, the FDA had delayed the review process for expanding Dupixent's label to include COPD treatment earlier this year. The delay was due to the agency's request for additional efficacy analyses from the BOREAS and NOTUS trials, which were submitted in May. This additional information was considered a major amendment to the supplemental Biologics License Application (sBLA), effectively extending the PDUFA date to September 27, 2024.

In May, Sanofi also presented data from the phase 3 NOTUS study at the American Thoracic Society International Conference, which confirmed the positive results from the BOREAS study. Both Sanofi and Regeneron remain optimistic that these additional analyses will support the approval of Dupixent for COPD and are committed to collaborating with the FDA.

Since its initial approval in 2017 for eczema, Dupixent has become a top-selling drug for both Sanofi and Regeneron. The drug has since received additional approvals for treating conditions such as asthma, rhinosinusitis, prurigo nodularis, and eosinophilic esophagitis, including pediatric indications for eczema and eosinophilic esophagitis.