Sanofi, Regeneron aim for major opportunity with Dupixent's COPD approval

After more than a decade without new treatments for chronic obstructive pulmonary disorder (COPD), the FDA has approved two new therapies within the last three months. The latest approval is for Regeneron and Sanofi's Dupixent, expanding its use to include COPD. This development marks a significant milestone, as Dupixent becomes the first biologic treatment for COPD patients in the United States. The drug is now approved for adults with inadequately controlled COPD who exhibit a raised blood eosinophil count (BEC).

COPD is a progressive inflammatory respiratory condition that restricts airflow from the lungs, making breathing difficult and leading to a decline in lung function. It is the fourth leading cause of death globally. In the U.S., approximately 2 million people suffer from COPD, with about 300,000 classified as having inadequately controlled disease. The new approval for Dupixent brings hope to these patients, who have long awaited new treatment options to manage symptoms such as breathlessness, coughing, wheezing, and exhaustion.

The path to this approval was not straightforward. U.S. regulators delayed their decision by three months to request additional results from two clinical trials. These trials demonstrated that Dupixent significantly reduced moderate or severe exacerbations and improved lung function in COPD patients. Regeneron and Sanofi's focused approach to targeting type 2 inflammation within the COPD patient population was a crucial factor in achieving these positive results.

Dupixent is one of several new medications emerging for COPD treatment. Three months ago, the FDA approved Verona Pharma’s Ohtuvayre, a selective dual inhibitor of the PDE3 and PDE4 enzymes. This drug can open airways and reduce inflammation, making it a versatile option for COPD patients. Additionally, GSK has reported positive results for its respiratory drug Nucala, which, when combined with inhaled maintenance therapy, reduced exacerbations in COPD patients over two years. Amgen and AstraZeneca are also exploring their asthma drug Tezspire as a potential COPD treatment, targeting patients with high BEC.

Regeneron and Sanofi are not stopping with Dupixent; they are conducting phase 3 trials for another COPD candidate, the IL-33 inhibitor itepekimab. Their strategic, phenotype-driven approach contrasts with the broader methods used by other companies, which often failed to advance COPD treatments. This method focuses on specific patient subgroups, such as those with type 2 inflammation or former smokers, to yield more effective results.

The approval of Dupixent for COPD is expected to significantly boost its already impressive sales. Last year, Dupixent generated $11.6 billion, a 33% increase from 2022. Analysts project that the COPD label expansion could add $3.5 billion in peak sales worldwide, potentially elevating Dupixent's sales to $20 billion by the end of the decade. This would make it one of the highest-selling drugs in history.

Therapies traditionally used to manage COPD include inhaled corticosteroids to reduce inflammation and bronchodilators to widen airways. Bronchodilators consist of long-acting beta agonists (LABAs) and long-acting muscarinic agonists (LAMAs). Some patients use a combination of these treatments, while others who cannot tolerate corticosteroids rely on a mix of LAMA and LABA.

In summary, the approval of Dupixent for COPD represents a significant advancement in treatment options for patients with this debilitating condition. The drug's success, combined with other emerging therapies, offers renewed hope and potential for improved quality of life for millions suffering from COPD.