Dupixent Gains First Biologic Approval for COPD

Sanofi and Regeneron have achieved a new milestone with their biologic drug, Dupixent, which has been approved by the FDA as an add-on therapy for chronic obstructive pulmonary disease (COPD). This approval marks Dupixent as the first biologic medicine in the U.S. for treating COPD, potentially benefiting approximately 300,000 adults suffering from poorly controlled disease characterized by a specific level of blood eosinophils, an inflammatory cell type that worsens airway obstruction. COPD is noted for causing progressive lung function decline and is the third leading cause of death globally.

Clinical evidence from two Phase III trials showed that Dupixent treatment led to a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. Additionally, the drug demonstrated statistical improvements in post-bronchodilator forced expiratory volume levels from the baseline at week 12, a secondary endpoint.

The safety profile of Dupixent in COPD was consistent with its safety in other approved indications. Common adverse events included viral infections, headache, and gastritis. This milestone follows the European Medicines Agency's approval of Dupixent as an add-on maintenance treatment for uncontrolled COPD in July.

Sanofi CEO Paul Hudson emphasized the significance of this approval, stating, "Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations."

This new approval adds to the extensive list of Dupixent's FDA-approved indications, which already include asthma and eczema. In 2023, Dupixent generated $11.6 billion in sales, with analysts predicting an additional $3.5 billion in revenue from the COPD indication, according to Fierce Pharma.

While Sanofi and Regeneron are currently the pioneers in this space, they may soon face competition. Earlier this month, GSK announced promising topline results from a Phase III trial of its injectable antibody Nucala for COPD. Although specific data has yet to be disclosed, GSK reported that Nucala led to a "statistically significant and clinically meaningful reduction" in the annual rates of moderate or severe exacerbations compared with placebo. Additionally, AstraZeneca and Amgen are planning a Phase III study for their biologic, Tezspire, in COPD.

Sanofi and Regeneron's achievement with Dupixent underscores the growing role of biologic medicines in treating chronic respiratory diseases. As more biologics enter the market for COPD, patients could have access to more effective therapies, potentially transforming the management of this debilitating condition and improving quality of life for many. The continued success and expansion of Dupixent indicate a promising future for biologic treatments in addressing unmet medical needs in respiratory diseases.