UK—The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils.
This approval specifically covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of LABA and LAMA if ICS is not appropriate.
The approval marks a milestone as the EMA becomes the first regulatory authority worldwide to approve Dupixent for COPD patients, ushering in the first new treatment approach for COPD in over a decade.
Consequently, this development introduces a novel option for approximately 220,000 adults in the European Union (EU).
Moreover, this approval represents the sixth approved indication for Dupixent in the EU and the seventh approved indication globally.
Sanofi SA and Regeneron Pharmaceuticals Inc. have been jointly developing dupilumab under a global collaboration agreement.
The approval is based on the results from the landmark phase 3 BOREAS and NOTUS studies.
These studies, which were separately published in The New England Journal of Medicine, evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with evidence of type 2 inflammation.
Notably, the safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications.
Speaking during the approval ceremony, Tonya Winders, President & CEO of Global Allergy & Airways Patient Platform, highlighted how COPD leads to suffering from breathlessness that severely limits a person’s ability to conduct everyday activities.
She emphasized that this approval welcomes a new era of disease management for patients and caregivers, whereby innovative treatments such as Dupixent will help manage this progressive and irreversible disease.
Similarly, Paul Hudson, Sanofi’s Chief Executive Officer, expressed his excitement about bringing to market the first biologic targeting an underlying cause of this devastating disease.
He noted that this approval has the potential to reduce COPD exacerbations and improve lung function, thus changing the treatment landscape for over 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils.
Hudson added that he looks forward to working with other regulators worldwide to bring this novel treatment approach to patients in more countries.
Commenting on the approval, George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President, and Chief Scientific Officer at Regeneron, described it as a long-awaited turning point for those who struggle to breathe even during simple tasks.
He acknowledged the risk of hospitalization, irreversible health decline, and feelings of hopelessness that these patients face.
Furthermore, he expressed pride in Dupixent’s potential to redefine the treatment landscape in yet another disease, demonstrating unprecedented improvements in exacerbations, lung function, and health-related quality of life across two large phase 3 trials.
The Food and Drug Administration (FDA) is still reviewing the drug, with a decision expected by September 27th, 2024, highlighting the global significance of the EMA’s recent clearance.
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