EU Approves Dupixent as First Targeted COPD Therapy

The European Medicines Agency (EMA) has made a groundbreaking move by approving Dupixent (dupilumab) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) marked by elevated blood eosinophils. This approval is targeted at patients already receiving a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or a LABA and LAMA combination if ICS is not suitable. This makes the EMA the first regulatory body globally to approve Dupixent for COPD, with further submissions under review in other regions including the US, China, and Japan.

Tonya Winders, CEO of the Global Allergy & Airways Patient Platform, highlighted the debilitating nature of COPD and the marginalization faced by patients due to the physical and mental toll of the disease. She expressed optimism about the introduction of Dupixent, which comes after over a decade of limited advancements in COPD treatment, marking a new era in disease management.

Paul Hudson, CEO of Sanofi, also shared his enthusiasm about this milestone. He noted that patients with uncontrolled COPD have long awaited a novel treatment approach. Dupixent, as the first biologic targeting an underlying cause of COPD, aims to reduce exacerbations and improve lung function, thus transforming the treatment landscape for over 200,000 patients in the EU with uncontrolled COPD characterized by raised blood eosinophils. Hudson emphasized the importance of rapid collaboration with other regulators to make this therapy available in more countries.

The approval of Dupixent is supported by data from the landmark phase 3 BOREAS and NOTUS studies. These studies, published in The New England Journal of Medicine, evaluated the effectiveness and safety of Dupixent in adults with uncontrolled COPD exhibiting type 2 inflammation, with blood eosinophil counts of 300 cells per µL or higher. All participants were on maximal standard-of-care inhaled therapies, predominantly triple therapy. In BOREAS (n=468) and NOTUS (n=470), Dupixent showed a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks compared to placebo, respectively. It also significantly improved lung function from baseline by 160 mL and 139 mL at 12 weeks, sustained up to 52 weeks, and improved health-related quality of life.

The safety profile of Dupixent in these trials was consistent with its known safety in other indications. Common side effects included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Adverse events such as back pain, COVID-19, diarrhea, headache, and nasopharyngitis were observed more frequently in Dupixent-treated patients than those on placebo.

George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, described the approval as a significant turning point for COPD patients, providing a first-in-class therapy that shows unprecedented improvements in exacerbations and lung function, as well as quality of life.

COPD is a progressive lung disease leading to significant health deterioration and economic burden due to recurrent acute exacerbations requiring systemic corticosteroid treatment or hospitalization. Smoking and exposure to harmful particles are major risk factors for COPD, although the disease can persist or develop even after quitting smoking. For over a decade, there have been no new treatment approaches approved for COPD.

Dupixent's approval marks its sixth indication in the EU and seventh globally, emphasizing its broad therapeutic potential across various chronic diseases driven by type 2 inflammation. The phase 3 BOREAS and NOTUS studies enrolled approximately 1,874 patients aged 40-85 years who were current or former smokers with moderate-to-severe COPD.

In summary, the EMA's approval of Dupixent for uncontrolled COPD offers a novel therapeutic option, bringing hope to many patients and marking a significant advancement in the treatment of this debilitating disease.