Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options.

Regeneron Pharmaceuticals Inc REGN and Sanofi SA’s SNY Dupixent recently gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago.

This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.

COPD often manifests as chronic bronchitis and emphysema, typically developing from prolonged exposure to irritants like cigarette smoke, air pollution, or occupational dust.

Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market

The condition impacts millions globally, with a 2023 analysis by DelveInsight reporting around 44 million diagnosed cases across seven major markets, with projections of continued growth at a 1.4% CAGR through 2034.

COPD management typically involves medications like bronchodilators, which ease breathing by relaxing airway muscles.

These drugs, often used in inhalers, can include steroids to reduce inflammation in severe cases. Common options include short—and long-acting bronchodilators like Albuterol, Ipratropium, and Aclidinium. LABAs and LAMAs are also prevalent, with combinations such as LABA+ICS (e.g., AstraZeneca Plc’s AZN Symbicort, GSK Plc’s GSK Advair) and LABA+LAMA (e.g., GSK’s Anoro Ellipta, Boehringer Ingelheim’s Stiolto Respimat) available for comprehensive treatment.

The introduction of Dupixent changes the treatment landscape by specifically targeting type 2 inflammation pathways (IL-4 and IL-13), which play a role in COPD patients with elevated eosinophils prone to frequent exacerbations.

The Phase 3 BOREAS trial demonstrated that DUPIXENT reduced moderate-to-severe exacerbations by 30% over 52 weeks and improved lung function, with prebronchodilator FEV1 increasing by 160 mL compared to 77 mL in the placebo group.

The drug also had a favorable safety profile, indicating its potential as a game-changer for those with type 2 inflammation.

Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc NASDAQ: AMGN/AstraZeneca’s tezepelumab, and GSK’s mepolizumab are in development, promising more options to transform COPD management.

On Wednesday, Regeneron announced that new and updated data from its hematology pipeline will be presented in 23 abstracts at the American Society of Hematology 2024 Annual Meeting.

Price Action: REGN stock traded lower by 0.98% to $812.92 at the last check on Wednesday.

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