Sanofi and Regeneron’s Dupixent Approved as First-in-World Treatment For Uncontrolled COPD

On July 3rd, Sanofi S.A. and Regeneron Pharmaceuticals, Inc. officially announced that their drug, IL-4 and IL-13 inhibitor Dupixent (dupilumab), was approved by the European Medicine Agency (EMA) as an add-on maintenance treatment for adult patients suffering with chronic obstructive pulmonary disease (COPD). This approval sets Dupixent as the first-in-world treatment approach for COPD after a decade of no new therapies. 

COPD’s Projected 600 Million Cases Addressed Through Dupixent as Novel Treatment Approach

According to the World Health Organization (WHO), COPD is considered the third-leading cause of death worldwide, accounting for 7,905 deaths for the year 2024. This commonly diagnosed lung disease is reported to cause restricted airflow resulting in breathing problems as a result of excessive phlegm. Multiple factors have been attributed as the pathological cause of the disease, however smoking is most prevalent, accounting for over 70% of COPD cases. In a modeling study, historical COPD prevalence from 2010 to 2018 was estimated using a recent meta-analysis, with risk factors from the Global Burden of Disease database. Subsequent results projected that global COPD prevalence would reach 600 million cases worldwide by 2050.

Dupixent’s approval marks a transformative moment for COPD patients, offering new hope and potentially improving their quality of life, emphasized George D. Yancopoulos, Board Co-chair, President, and Chief Scientific Officer at Regeneron. “The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalization, irreversible health decline and feelings of hopelessness. With this approval, we are proud that Dupixent has the potential to redefine the treatment landscape in yet another disease, as a first-in-class therapy.” 

Dupixents’s Phase 3 Trial Safety and Efficacy Boasts Over 30% Reduction in COPD

Dupixent successfully obtained approval based on results from its Phase 3 BOREAS and NOTUS trials, which evaluated the drug’s safety and efficacy in adults suffering from uncontrolled COPD with evidence of type 2 inflammation (specifically, blood eosinophils ≥300 cells per μL). In the BOREAS trial, involving 468 participants, the drug demonstrated significant improvements in lung function and additional reduction in exacerbations compared to the placebo. The NOTUS trial, which included 470 participants, focused on the drug’s safety and showed a reduction in exacerbations. Participants receiving Dupixent also experienced improved quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ), compared to those receiving the placebo.

Over a period of 52 weeks, consistent improvements in patient condition were observed across both trials. During the initial period, significant improvements in lung function (pre-bronchodilator FEV1) were observed, with increases of 160 mL and 139 mL at the 12-week mark, compared to the respective 77 mL and 57 mL observed with the placebo. The primary outcome measures indicated a 30% and 34% decrease in the annual rate of moderate to severe COPD exacerbations experienced by the participants.

Furthermore, Dupixent was able to demonstrate a consistent benefit throughout various patient subgroups. These included those with a higher baseline fractional exhaled nitric oxide (FeNO), a marker for airway inflammation. These studies demonstrated that Dupixent led to improved outcomes compared to the placebo, regardless of the patient’s baseline fractional exhaled nitric oxide (FeNO), smoking status, history of exacerbations, or baseline lung function.

Dupixent’s Mechanism of Action a Nod to Regeneron’s VelocImmune Technology

The drug was developed through Regeneron’s VelocImmune technology. This innovative technology produces optimized human monoclonal antibodies which will target interleukin-4 (IL-4) and interleukin-13 (IL-13). However, it will not exert any immunosuppressive effects. The mechanism is able to inhibit the signaling of IL-4 and IL-13 which in return decreases type 2 inflammation. Extensive research in phase 3 trials demonstrated Dupixent’s potential in becoming a viable solution for the 220,000 adults in the European Union (EU) struggling with COPD.

The EMA’s approval of Dupixent by Sanofi and Regeneron marks an advancement in COPD treatment, providing patients with an alternative to current therapies. This approval expands treatment options for adults, potentially enhancing their quality of life and offering renewed hope for managing the condition effectively

Author

Denisse Sandoval