Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).
The regulator’s decision, which makes Dupixent the first biologic medicines approved in the US for COPD, specifically applies to adults with inadequately controlled cases of the condition and an eosinophilic phenotype.
COPD is a chronic respiratory disease that causes progressive lung function decline and results in symptoms such as persistent cough, excessive mucus production and a shortness of breath.
Sanofi and Regeneron have outlined that there are approximately 300,000 patients in the US who will be eligible for treatment with Dupixent, a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways shown to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases.
The approval was based on positive results from the late-stage BOREAS and NOTUS trials of the therapy in adults with uncontrolled COPD and blood eosinophils of at least 300 cells per μL. All patients were on maximal standard-of-care inhaled therapy and nearly all were receiving triple therapy.
The primary endpoint was met in both studies, with Dupixent demonstrating a 30% and 34% reduction in annualised moderate or severe COPD exacerbations compared to placebo over 52 weeks in BOREAS and NOTUS, respectively.
Improvements in lung function in Dupixent-treated patients were sustained at 52 weeks, and the therapy was also associated with greater improvements in health-related quality of life compared to placebo at one year, as assessed by a four-point improvement on the St George’s Respiratory Questionnaire.
Dupixent was recently approved in the UK, EU and China for uncontrolled COPD, with submissions currently under review with other regulatory authorities globally.
Rippon Ubhi, country lead, Sanofi UK and Ireland, said: “This approval represents a significant shift in the longstanding treatment landscape for COPD patients. It marks the first time in more than a decade that we’ve seen a meaningful change in the treatments available to physicians to combat this devastating disease. Respiratory illnesses are the third biggest cause of death in the UK behind cancer and cardiovascular disease. Over 20,000 people with COPD die every year in the UK.
“[Dupixent] has been clinically shown to reduce COPD exacerbations and improve lung function, and it is our priority to work with regulatory bodies to ensure patients in the UK can access this important treatment option as soon as possible.”