For years, patients with chronic obstructive pulmonary disease (COPD) have faced limited treatment options. But now, a new era of hope is dawning. Regeneron Pharmaceuticals Inc (REGN) and Sanofi SA (SNY) have achieved a major breakthrough with their drug, Dupixent, earning FDA approval for the treatment of COPD. This marks the sixth U.S. indication for Dupixent since its initial approval for atopic dermatitis seven years ago, solidifying its position as a versatile therapeutic agent.
The significance of Dupixent’s approval lies in its unique approach. For the first time, patients with COPD have access to a targeted therapy, a game-changer for this progressive lung condition that makes breathing difficult due to obstructed airflow. COPD often manifests as chronic bronchitis and emphysema, typically stemming from prolonged exposure to irritants like cigarette smoke, air pollution, or occupational dust.
This condition affects millions worldwide. A 2023 analysis by DelveInsight revealed an estimated 44 million diagnosed cases across seven major markets, with projections suggesting a continued growth rate of 1.4% CAGR through 2034.
Traditionally, COPD management has relied on medications like bronchodilators, which work by relaxing airway muscles to ease breathing. These drugs, often administered through inhalers, may include steroids to reduce inflammation in severe cases. Common options include short-acting and long-acting bronchodilators like Albuterol, Ipratropium, and Aclidinium. LABAs and LAMAs are also widely used, with combinations like LABA+ICS (e.g., AstraZeneca Plc’s Symbicort, GSK Plc’s Advair) and LABA+LAMA (e.g., GSK’s Anoro Ellipta, Boehringer Ingelheim’s Stiolto Respimat) offering comprehensive treatment regimens.
Dupixent’s arrival completely changes the treatment landscape. By targeting type 2 inflammation pathways (IL-4 and IL-13), Dupixent addresses the specific inflammatory processes often found in COPD patients with elevated eosinophils, who are prone to frequent exacerbations.
The Phase 3 BOREAS trial showcased Dupixent’s impressive efficacy. Over 52 weeks, the drug reduced moderate-to-severe exacerbations by 30% and led to improved lung function, with prebronchodilator FEV1 increasing by 160 mL compared to 77 mL in the placebo group. Furthermore, Dupixent demonstrated a favorable safety profile, underscoring its potential as a transformative therapy for patients with type 2 inflammation.
Adding to the optimistic outlook, multiple mid-stage drugs are currently in development, promising even more treatment options to revolutionize COPD management. These include Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc/AstraZeneca’s tezepelumab, and GSK’s mepolizumab.
The future of COPD treatment is brighter than ever. With Dupixent’s FDA approval and the promising pipeline of emerging therapies, patients now have reason to be optimistic about managing this chronic condition.
