Dupixent Fills Current Gap in COPD Biologics

Regeneron and Sanofi's Dupixent (dupilumab) has recently received approval from the European Medicines Agency (EMA) as the first targeted therapy for chronic obstructive pulmonary disease (COPD). This landmark approval addresses a significant gap in the treatment landscape for COPD, a condition that has seen little advancement in biologic therapies over the past decade.

Dupixent, which targets interleukin-4 (IL4) and interleukin-13 (IL13), has been approved by the EMA as an add-on maintenance treatment. It is designed to be used alongside existing COPD therapies such as inhaled corticosteroids and bronchodilators, which help control inflammation and relax the airways in the lungs.

According to Asiyah Nawab, a healthcare analyst at GlobalData, the approval of Dupixent fills a crucial void in the market. Key opinion leaders (KOLs) interviewed by GlobalData have expressed optimism about the drug, highlighting its novel pathway, which not only offers anti-eosinophil effects but also presents anti-mucous benefits.

Dupixent is already an established treatment for severe asthma, atopic dermatitis, and other eosinophilic conditions. In 2023, the drug generated $11.59 billion in sales, marking a 33% increase from the previous year. The recent approval for COPD is based on robust data from two Phase III studies, named BOREAS and NOTUS. These studies showed that Dupixent led to significant reductions in moderate or severe COPD exacerbations over a 52-week period, with reductions of 30% and 34%, respectively.

Nawab emphasized that the clinical trial data provides a substantial advantage for Dupixent in the COPD market, potentially positioning it ahead of other biologics currently in the development pipeline.

While the EMA has given the green light for Dupixent, the drug's application for the same indication in the United States has faced a delay. Regeneron and Sanofi announced that the US Food and Drug Administration (FDA) has pushed back its decision by three months, setting a new target action date for September 27, 2024. Despite the delay, the FDA has not raised any concerns regarding the drug's likelihood of approval.

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