Sanofi, Regeneron get a step closer on Dupixent COPD nod with FDA priority review

Regeneron and Sanofi have reached another milestone as they look to add to their megablockbuster immunology drug Dupixent a new U.S. indication for uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation.

This comes as the FDA has accepted the companies’ application and designated it for priority review with a target action date of June 27 this year. 

An approval would make it available as an add-on maintenance treatment for adults with uncontrolled COPD with type 2 inflammation, making in the process Dupixent the first biologic therapy for COPD and the first new treatment approach for the disease in more than a decade, and could also add an extra $3.5 billion in peak sales to the drug's already impressive coffers. 

The submission is backed by results of the phase 3 BOREAS and NOTUS trials of patients on maximal standard of care inhaled therapy (most on triple therapy) that showed Dupixent reduced moderate or severe acute COPD exacerbations by 30% and 34%, respectively, when compared to placebo. Dupixent also produced significant lung function improvement within 12 weeks, which sustained through 52 weeks.

COPD is a respiratory disease that causes progressive lung function decline. Symptoms include persistent cough, breathlessness and excessive mucus production that can lead to anxiety, depression and sleep disturbances. In the U.S., approximately 300,000 people live with the condition.

Sanofi and Regeneron are investigating another COPD candidate, itepekimab, for former smokers, which make up roughly 70% of the disease population. Enrollment is underway for two phase 3 trials of itepekimab, with a readout expected in 2025. The drug is an IL-33 inhibitor, while Dupixent inhibits the IL-4 and IL-13 pathways.

A nod for COPD would give Dupixent its seventh global indication. A week ago, Japan signed off on Dupixent as an add-on therapy for those 12 and older with chronic spontaneous urticaria (CSU), a condition that causes hives. The blessing came four months after the FDA rejected Dupixent for CSU, telling the companies it needed to see more compelling efficacy data.

Dupixent was originally approved in 2017 for atopic dermatitis (eczema). That was followed by nods for asthma, chronic rhinosinusitis, eosinophilic esophagitis and prurigo nodularis. The anti-inflammatory drug raked in a major $11.6 billion in sales last year, which was a 33% increase from 2022.

Last year, analysts at Evercore ISI projected that a label expansion for COPD would add a cool $3.5 billion in peak sales for Dupixent worldwide. They based their figure on 30% uptake of the treatment for those who are eligible. The addition would put Dupixent’s sales potential at $20 billion by the end of this decade, making it one of the world's biggest selling drugs of all time.