A Breath of Fresh Air: The Anticipated Rise of Dupixent in COPD Treatment

Dupixent’s Path to Greater Heights

Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) have a reason to breathe easier as their blockbuster drug Dupixent (dupilumab) edges closer to gaining approval for chronic obstructive pulmonary disease (COPD), amplifying its already substantial success in treating asthma and eosinophilic esophagitis.

Dupixent, a therapy with a thriving track record, is projected by GlobalData to potentially see global sales skyrocket to $21.4 billion by 2029, building on its impressive performance that reaped around $11.6 billion in global sales in 2023.

The Demand for Innovation in COPD Treatment

The landscape for COPD treatment is evolving rapidly, with a burgeoning demand for advanced therapies to complement the current standard treatments such as short- or long-acting beta-2 agonists, muscarinic antagonists, inhaled corticosteroids, and phosphodiesterase inhibitors. The steady progression of COPD necessitates additional maintenance therapies, presenting a prime opportunity for groundbreaking solutions like Dupixent to revolutionize patient care.

“These therapies are tolerable by patients; however, the progressive nature of COPD has created a need for additional maintenance therapy alongside the standard of care,” remarked GlobalData Pharma Analyst Asiyah Nawab, emphasizing the urgency for transformative interventions in the field.

Promising Clinical Results and Regulatory Milestones

Phase III clinical trials for Dupixent have shown compelling outcomes, with the interleukin-4 and interleukin-13 inhibitor meeting primary endpoints efficiently. The trials demonstrated that Dupixent effectively reduced moderate or severe acute COPD exacerbations by 30% and 34% over a year, while also enhancing lung function consistently over a span of 52 weeks compared to a placebo.

The supplemental Biologics License Application (sBLA) submitted by Sanofi and Regeneron for Dupixent as a COPD maintenance therapy is currently under US FDA review, with an action date set for June 27. GlobalData’s expert insights echo optimism, hinting at a probable green light for Dupixent based on feedback from key opinion leaders.

However, Dupixent is not the sole contender in the race for novel COPD treatments. Verona Pharma (VRNA) is also awaiting FDA approval for ensifentrine, a dual PDE3/4 inhibitor, supported by successful late-stage trials. The FDA verdict is expected on June 23, shaping a competitive and evolving landscape in COPD management.