The Biologic Drug Dupixent, Developed By Sanofi and Regeneron, Gained New FDA Approval For Treatment Of COPD

On Friday, the US FDA approved Sanofi and Regeneron's Dupixent to treat chronic obstructive pulmonary disease (COPD), a progressive lung disease common among smokers. It is the biologic add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease, administered via injection every other week. 

Results of lung damage indicate that inhaled irritants cause breathing problems as well as inflammation in the airways. However, long-term exposure to irritants results in the occurrence of disease, which is the reason why it is common in active smokers, but COPD can also be developed in passive smokers. Common treatments include medicines that help to dilate airways and reduce inflammation.

Dupixent is an IL-13 and IL-4 receptor antagonist monoclonal antibody directed against key inflammation pathways in the body. COPD targets type 2 inflammation, which is characterized by the accumulation of eosinophils. The FDA approved the treatment of COPD based on two Phase 3 trials that resulted in a significant decrease in the frequency of moderate to severe side effects compared to placebo in adults who received standard inhaled therapies. Developed as a collaboration between Sanofi and Regeneron, Dupixent counted  €10.7 billion, or around $11.6 billion, in sales for 2023. It was initially approved in 2017 for atopic dermatitis. Dupixent has the ability to treat six separate respiratory and skin diseases.

Rowe said, “Given the success we’ve had in these other disorders, we think there’s a strong rationale for COPD as well.” Traditionally, treatments for COPD had always been older inhaled therapies; the game is changing. In June, the FDA approved Verona Pharma's Ohtuvayre, an inhalable drug targeting inflammation and airway dilation. 

Dupixent will also contend with another set of biologics; GSK's Nucala, an IL-5 pathway blocker that just released promising Phase 3 results in a study for COPD, will also be resubmitted from its previous FDA rejection in 2018. The FDA initially voted on Dupixent in COPD last June but asked for more time to evaluate some extra data. Chinese regulators also approved Dupixent for COPD days after the first European approval in July.