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EMA approves Dupixent for treating uncontrolled COPD

In a huge step forward in COPD treatment, giving patients and healthcare providers fresh hope for controlling this gruelling condition, the European Medicines Agency (EMA) has recently approved Dupixent (dupilumab) as an add-on maintenance medication for individuals with uncontrolled chronic obstructive pulmonary disease (COPD), characterised by elevated blood eosinophil counts. This approval specifically targets patients already on a regimen of inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), and long-acting muscarinic antagonist (LAMA), or on LABA and LAMA when ICS is inappropriate. Significantly, the EMA has become the first global regulatory body to approve Dupixent for COPD patients. Additional applications are under consideration by regulatory bodies in the United States, China, and Japan.

Tonya Winders, President & CEO of Global Allergy & Airways Patient Platform, emphasised the significance of this development, stating, "As a progressive and devastating disease, COPD causes breathlessness, which limits a person's ability to perform daily activities such as walking up the stairs or to the mailbox. Many patients feel marginalised and alone as a result of the disease's physical and mental burden. After more than a decade of limited treatment advancements for those living with uncontrolled COPD, we have entered a new era of disease management for patients and carers, and we welcome the addition of innovative, new treatments like Dupixent to help manage this progressive and irreversible disease."

Sanofi's CEO, Paul Hudson, expressed his enthusiasm for the approval, saying, "Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function. With today's approval of Dupixent, we can change the therapeutic landscape for the more than 200,000 patients in the EU who have uncontrolled COPD and elevated blood eosinophil levels. We look forward to collaborating with other authorities worldwide as soon as possible to provide this innovative therapeutic method to patients in other countries."

The decision by the EMA is grounded in the results from the pivotal phase 3 BOREAS and NOTUS studies, as published in The New England Journal of Medicine. These studies evaluated the safety and effectiveness of Dupixent in individuals with uncontrolled COPD characterised by type 2 inflammation, indicated by blood eosinophil counts of 300 cells per μL or higher. All individuals were receiving maximal standard-of-care inhalation treatment. In terms of efficacy, Dupixent reduced the annualised rate of moderate or severe COPD exacerbations by 30% and 34% over 52 weeks in BOREAS (n = 468) and NOTUS (n = 470), respectively, compared to placebo groups. Furthermore, improvements in lung function (pre-bronchodilator FEV1) were detected as early as weeks 2 and 4 and persisted for 52 weeks in both groups. Health-related quality of life also increased, with statistically significant results in BOREAS and nominally significant results in NOTUS.

The investigations found that the safety outcomes were broadly in line with Dupixent's recognised safety profile. Common adverse effects included injection site reactions, conjunctivitis, and eosinophilia, among other things. Back pain, COVID-19, diarrhoea, headache, and nasopharyngitis were among the more common side effects reported in COPD patients.

George D. Yancopoulos, M.D., Ph.D., Regeneron's Board Co-Chair, President, and Chief Scientific Officer, commented on the approval, saying, "The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even during the simplest of tasks, while also facing the risk of hospitalisation, irreversible health decline, and feelings of hopelessness. With this approval, we are proud that Dupixent has the potential to reshape the treatment landscape for yet another disease as a first-in-class therapy that has demonstrated unprecedented improvements in exacerbations and lung function, as well as improved health-related quality of life in two large phase 3 trials."

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