Dupixent now approved in EU to treat uncontrolled COPD
Treatment indicated as add-on for adults with type 2 inflammation
Dupixent (dupilumab) has been approved by the European Commission as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD).
Specifically, the therapy from Sanofi and Regeneron Pharmaceuticals is now indicated for COPD patients in the European Union who have evidence of type 2 inflammation, characterized by an elevation of immune cells called eosinophils.
Eligible patients also must have poorly controlled disease despite already being on maximal standard-of-care inhaled therapies, as appropriate. Such treatments include corticosteroids, long-acting beta 2-agonists, and long-acting muscarinic antagonists.
The decision, which followed a positive recommendation by a European Medicines Agency’s committee in May, makes Dupixent the first new COPD treatment to be cleared in the EU in more than a decade. It also is the first biologic — a treatment derived from living organisms — to be approved for COPD in the region.
“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,” Paul Hudson, Sanofi’s CEO, said in a company press release.
“With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils,” Hudson added. “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.”
EU approval of Dupixent for COPD is first in world
Regeneron called the European Commission’s decision the “first-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils.”
Similar regulatory applications seeking Dupixent’s approval for COPD are now under review in the U.S., China, and Japan. A decision in the U.S. is due by Sept. 27, after being delayed by three months to allow regulators time to review requested additional trial data.
COPD is now the sixth indication for which Dupixent is approved in the EU, and the seventh approved indication worldwide. The other conditions for which the treatment is approved are also characterized by type 2 inflammation.
“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 demonstrating unprecedented improvements on exacerbations and lung function, as well as improving health-related quality of life across two large Phase 3 trials,” said George D. Yancopoulos, MD, PhD, Regeneron’s board co-chair, president, and chief scientific officer.
“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,” added Yancopoulos, who is also one of the principal inventors of Dupixent.
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 demonstrating unprecedented improvements on exacerbations and lung function, as well as improving health-related quality of life across two large Phase 3 trials.
Dupixent is an antibody-based therapy designed to suppress type 2 inflammation. Such inflammation has been implicated in the lung inflammation and respiratory symptoms that characterize COPD, a progressive inflammatory lung disease. The treatment is injected subcutaneously, or under the skin, once every two weeks.
Treatment shown in trials to reduce exacerbations, improve lung function
The approval and other regulatory applications under review for Dupixent are supported by the findings of two placebo-controlled Phase 3 clinical trials: BOREAS (NCT03930732) and NOTUS (NCT04456673).
Each of the studies involved more than 900 current or former smokers with uncontrolled moderate to severe COPD and evidence of type 2 inflammation. All patients were on maximal standard-of-care inhaled therapy.
Participants in both trials were randomly assigned to receive either Dupixent or a placebo, every two weeks, on top of standard inhaled therapy.
The results showed that Dupixent reduced moderate or severe COPD exacerbations by about 30% and improved lung function relative to the placebo. These benefits were observed across predefined subgroups based on airway inflammation, smoking status, lung function, and exacerbation history at the study’s start, Regeneron stated in the release.
Also, the therapy was associated with improvements in health-related life quality.
Dupixent’s safety profile in COPD has been largely consistent with its known profile in other indications. Adverse events most commonly reported with Dupixent in COPD trials included back pain, COVID-19 infection, diarrhea, headache, and the common cold.
“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,” said Tonya Winders, president and CEO at Global Allergy & Airways Patient Platform, which supports and empowers patients with airway diseases and allergies.
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