FDA Approves Sanofi/Regeneron's Dupixent for Uncontrolled COPD

Sanofi and Regeneron's Dupixent (dupilumab) has received approval from the US Food and Drug Administration (FDA) as an add-on maintenance therapy for chronic obstructive pulmonary disease (COPD). This marks the first time a biologic medicine has been approved for COPD in the US. The approval is specifically for adults with inadequately controlled COPD and an eosinophilic phenotype.

COPD, a chronic respiratory condition, leads to progressive deterioration in lung function and manifests symptoms such as persistent coughing, excessive mucus production, and difficulty in breathing. Sanofi and Regeneron estimate that around 300,000 patients in the US may qualify for treatment with Dupixent. This fully human monoclonal antibody works by inhibiting the signaling pathways of interleukin-4 and interleukin-13, which are key drivers of type 2 inflammation that significantly contributes to various related diseases.

The FDA's approval was grounded on favorable outcomes from the late-stage BOREAS and NOTUS trials. These studies focused on adults with uncontrolled COPD and blood eosinophil counts of at least 300 cells per μL. All participants were already on maximal standard-of-care inhaled therapies, with nearly all receiving triple therapy.

The primary endpoint was successfully achieved in both trials. Dupixent showed a 30% reduction in annualized moderate or severe COPD exacerbations in the BOREAS trial and a 34% reduction in the NOTUS trial, compared to placebo, over 52 weeks. Additionally, patients treated with Dupixent experienced sustained improvements in lung function over the same period. The therapy also provided greater enhancements in health-related quality of life compared to placebo, as measured by a four-point improvement on the St George’s Respiratory Questionnaire over one year.

Dupixent has also recently gained approval in the UK, EU, and China for treating uncontrolled COPD. Submissions for approval are currently being reviewed by other regulatory authorities worldwide.

Rippon Ubhi, the country lead for Sanofi UK and Ireland, remarked on the significance of this approval, stating that it represents a major shift in the long-standing treatment landscape for COPD patients. This is the first significant change in over a decade in the treatments available to physicians to tackle this debilitating disease. In the UK, respiratory illnesses are the third leading cause of death, following cancer and cardiovascular diseases. Each year, over 20,000 individuals in the UK succumb to COPD.

Ubhi emphasized the clinical evidence supporting Dupixent’s efficacy in reducing COPD exacerbations and improving lung function. He stressed that Sanofi’s priority is to collaborate with regulatory bodies to ensure that patients in the UK have timely access to this vital treatment option.

This development underscores a potentially new era in COPD management, focusing on biologic treatments that target specific inflammatory pathways, offering hope to countless patients suffering from this chronic and debilitating condition.