Sanofi and Regeneron's Dupixent Approved in Europe as First Biologic for COPD

Regeneron and Sanofi's Dupixent has become the first biologic treatment approved for chronic obstructive pulmonary disease (COPD) in Europe. This milestone marks a significant advancement, as COPD is the third-leading cause of death globally and has seen little progress in treatment options for over a decade.

The European Medicines Agency (EMA) recently approved Dupixent for COPD treatment, just a week after the FDA approved Verona Pharma's Ohtuvayre. Both approvals signal a new era in managing this debilitating condition. COPD restricts airflow in the lungs, making it difficult for patients to breathe.

Tonya Winders, CEO of the Global Allergy & Airways Patient Platform, expressed optimism about the approval, highlighting the significance for patients and caregivers. Dupixent’s approval by the EMA follows a three-month delay in the U.S., where regulators requested additional data from clinical trials. Despite the delay, European regulators found the phase 3 trial results satisfactory and promptly gave their approval.

Dupixent is approved as an add-on maintenance therapy to existing treatments like inhaled corticosteroids and bronchodilators. These conventional treatments help reduce inflammation and relax lung muscles, but Dupixent adds a novel approach by targeting specific biological pathways. Meanwhile, Ohtuvayre has been approved in the U.S. as both an add-on and a standalone treatment.

Clinical trials for Dupixent, specifically the BOREAS and NOTUS trials, demonstrated a substantial reduction in moderate or severe exacerbations over a 52-week period. The results showed a reduction of 30% and 34% compared to a placebo. In comparison, Verona's Ohtuvayre trials reported a 40% reduction in flare-ups after 24 weeks.

GlobalData analysts have underscored the importance of Dupixent in addressing a significant market gap for COPD treatments. Key opinion leaders interviewed by GlobalData expressed positive views, noting the drug’s unique pathway and its ability to reduce mucus production, alongside its anti-eosinophil effects.

Earlier projections by Evercore ISI analysts estimated that the approval of Dupixent for COPD could boost its annual sales by $3.5 billion, potentially reaching $20 billion in peak sales. GlobalData forecasts that Dupixent’s sales will hit $23.6 billion by 2030. Dupixent has already been on the market for seven years and has received approvals for other conditions like eczema, asthma, rhinosinusitis, eosinophilic esophagitis, and prurigo nodularis. Last year, it ranked sixth in global sales with $11.6 billion.

The European approval will make Dupixent available to over 200,000 COPD patients, offering a new and effective treatment option for a condition that remains a leading cause of death worldwide.