EU Makes First-in-World Approval of Dupixent as Targeted Therapy for Uncontrolled COPD

Sanofi announced on July 3, 2024 that the European Medicines Agency (EMA) gave its approval to Dupixent (dupilumab), a human monoclonal antibody approved for numerous indications in more than 60 countries, for additional, maintenance treatment of adults with uncontrolled chronic obstructive pulmonary disease (COPD) (1). According to Sanofi’s press release, EMA is the first regulatory body in the world to approve Dupixent for this purpose, but submissions are currently under review in the United States, China, and Japan, among others.

The type of COPD for which EMA approved Dupixent is characterized by raised blood eosinophils, and in patients who are already being treated with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-antagonist (LABA), and a long-acting muscarinic antagonist (LAMA), or both LABA and LAMA if ICS is not appropriate (1).

“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,” said Paul Hudson, Sanofi chief executive officer. “We can change the treatment landscape for the more than 200,000 patients throughout the EU [European Union] living with uncontrolled COPD with raised blood eosinophils. We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries.”

Two Phase III studies, published in 2023 and 2024 in the New England Journal of Medicine, showed that dupilumab patients experienced, respectively, a 30% and 34% reduction in moderate to severe COPD exacerbations over one year compared to placebo, as well as improvements in lung function—sometimes seen as early as weeks two to four in the studies—and quality of life, at least nominally significant in one study and statistically significant in the other (2,3).

More than 900,000 patients worldwide are being treated with Dupixent currently, Sanofi said, for indications from atopic dermatitis to asthma to chronic rhinosinusitis with nasal polyposis, and others (1).

Tonya Winters, president and CEO of Global Allergy & Airways Patient Platform, said the EMA approval follows a long wait for better available therapies for patients with uncontrolled COPD.

“As a progressive and devastating disease, COPD leads to suffering from breathlessness that limits a person’s ability to conduct everyday activities such as walking up the stairs or to the mailbox,” Winters said. “Many patients feel marginalized and isolated because of the physical and mental toll of the disease. After more than a decade of limited treatment advancements for those living with uncontrolled COPD, we are now in a new era of disease management for patients and caregivers, and we welcome the addition of innovative, new treatments such as Dupixent to help manage this progressive and irreversible disease.”

References

1. Sanofi. Dupixent Approved in the EU as the First-Ever Targeted Therapy for Patients with COPD. Press Release. July 3, 2024.
2. Bhatt, S.P.; Rabe, K.F.; Hanania, N.A.; et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N. Engl. J. Med. 2023, 389 (3) 205–214. DOI: 10.1056/NEJMoa2303951
3. Bhatt, S.P.; Rabe, K.F.; Hanania, N.A.; et al. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N. Engl. J. Med. 2024, 390 (24) 2274–2283. DOI: 10.1056/NEJMoa2401304