Words by Isabel O’Brien
Sanofi and Regeneron have announced that dupilumab has received FDA approval as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. This approval makes dupilumab the first biologic medicine available for this specific COPD patient group in the US, following recent regulatory greenlights in the EU and China.
“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,” said Dr Jean Wright, Chief Executive Officer, The COPD Foundation. She also welcomed the approval of this new therapeutic option to help patients gain better control of their disease.
The approval was based on two pivotal phase III trials—BOREAS and NOTUS—where dupilumab significantly reduced moderate or severe COPD exacerbations and demonstrated meaningful improvements in lung function and quality of life measures compared to placebo.
The estimated patient population eligible for dupilumab’s new indication is approximately 300,000 adults in the US with an eosinophilic phenotype. COPD remains a major health burden as the fourth leading cause of death globally, often linked to smoking but also caused by environmental factors such as air pollution.
“This latest FDA approval for [dupilumab] represents new hope for the hundreds of thousands of COPD patients in the US who can sometimes struggle just to breathe during their everyday lives,” said Dr George D. Yancopoulos, Board Co-Chair, President, and Chief Scientific Officer, Regeneron. “[It] has a proven track record as a first-in-class medicine, providing benefit to the many patients suffering from type 2 inflammatory-related diseases such as asthma and atopic dermatitis (AD),” he added.
With dupilumab already a blockbuster for Sanofi and Regeneron in asthma, AD and other therapy areas, this approval could boost its trajectory even further. The drug generated €10.72bn in global sales last year, and analysts believe it could reach more than €21bn by 2030.
