The FDA has approved Dupixent for adults with inadequately controlled COPD and an eosinophilic phenotype.

RT’s Three Key Takeaways:

  1. FDA Approval of Dupixent for COPD: Dupixent (dupilumab) has been approved by the FDA as an add-on treatment for adults with inadequately controlled COPD and an eosinophilic phenotypet.
  2. Positive Trial Results: Data from two phase 3 trials (BOREAS and NOTUS) showed that Dupixent significantly reduced COPD exacerbations and improved lung function in patients on maximal standard-of-care therapy, with a 30-34% reduction in exacerbation rates and measurable lung function improvements.
  3. Safety and Side Effects: The safety profile of Dupixent in COPD was consistent with its known effects in other approved indications. While some adverse events were more common, such as viral infections and headaches, they were generally manageable, with cholecystitis being a less common but notable occurrence.

Regeneron Pharmaceuticals Inc and Sanofi announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 

Dupixent is the first biologic medicine approved in the US to treat these patients.  

“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion, and unpredictable hospitalization. These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home,” says Jean Wright, MD, chief executive officer at The COPD Foundation, in a release. “We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”

Phase 3 Trials

The FDA approval is based on data from two phase 3 trials (BOREAS and NOTUS) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy) with inadequately controlled COPD and blood eosinophils ≥300 cells per μL. 

Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):

  • 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, the primary endpoint.
  • 74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.
  • 51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks, as assessed by a 4-point improvement on the St. George’s Respiratory Questionnaire (SGRQ).

Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. In pooled BOREAS and NOTUS data, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reaction, rhinitis, eosinophilia, toothache, and gastritis. While less common, cholecystitis was reported in 0.6% of patients on Dupixent compared to 0.1% of patients on placebo.

“Dupixent has already shown it can revolutionize the treatment paradigm of many diseases driven in part by type 2 inflammation with high unmet medical needs, with one million patients being treated globally across all currently approved indications,” says Paul Hudson, chief executive officer at Sanofi, in a release. “With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations.”

The FDA evaluated Dupixent under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. In July 2024, Regeneron and Sanofi announced the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Submissions are currently under review with other regulatory authorities around the world, including in Japan.