FDA Approves Dupixent as First-Ever Biologic Treatment for Chronic Obstructive Pulmonary Disease

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The FDA has approved Regeneron and Sanofi’s Dupixent (dupilumab) as the first-ever biologic treatment for adults with chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. According to the company, the regulatory action was based on results from the Phase III BOREAS and NOTUS trials, which demonstrated that Dupixent significantly reduced the rate of moderate to severe COPD exacerbations and improved lung function compared to placebo.¹

“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,” said Jean Wright, MD, CEO, The COPD Foundation, in a press release. “We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”

BOREAS and NOTUS were replicate, randomized, double-blind, placebo-controlled trials that evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with moderate-to-severe COPD with an eosinophilic phenotype, as defined by blood eosinophils ≥300 cells per µL. The trials, which enrolled 1,874 patients between the ages of 40 and 85 years, ran for 52 weeks. During this time, patients in both studies received Dupixent or placebo every two weeks added to a maximal standard-of-care inhaled triple therapy.

The primary endpoint was to evaluate the annualized rate of acute moderate or severe COPD exacerbations. Secondary endpoints included change from baseline in lung function at 12 and 52 weeks compared to placebo and safety.

Results found that Dupixent reduced the rate of moderate to severe COPD exacerbations by 30%-34% and improved lung function by 68-74 mL. Additionally, Dupixent improved patients' quality of life, with a 51% response rate versus 43%-47% for placebo on the St. George's Respiratory Questionnaire.

In both trials, safety results were found to be consistent with the known safety profile of Dupixent in its approved indications. Common adverse events found in patients treated with Dupixent compared to placebo included viral infection; headache; nasopharyngitis; back pain; diarrhea; arthralgia; urinary tract infection; local administration reaction; rhinitis; eosinophilia; toothache; and gastritis.¹

According to the World Health Organization, COPD is the third leading cause of death globally, with 3.23 million deaths reported in 2019. Close to 90% of all COPD-related deaths occur in people under the age of 70 years old in low- and middle-income countries (LMIC). In high-income countries, tobacco smoke accounts for approximately 70% of COPD cases and 30% to 40% in LMIC, with household air pollution also being cited as a major factor.²

“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,” said Paul Hudson, CEO, Sanofi, in the press 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.”

Dupixent was approved for this indication under Priority Review by the FDA. Back in July, it was approved by the European Commission for patients with COPD, with additional regulatory reviews underway worldwide.¹

References

1. Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. GlobeNewswire. September 27, 2024. Accessed September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html

2. Chronic obstructive pulmonary disease (COPD). WHO. March 16, 2023. Accessed September 27, 2024. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)