Sanofi and Regeneron’s Dupixent set for large gains with likely COPD approval

Sanofi (NASDAQ:SNY) and Regeneron Pharmaeuticals (NASDAQ:REGN) Dupixent (dupiliumab), already a blockbuster drug approved for several indications, including asthma and eosinophilic esophagitis, is poised for further gains as it is likely to gain approval for chronic obstructive pulmonary disease.

Dupixent sales could reach $21.4B worldwide by 2029, projects GlobalData. The therapy brought in global sales of ~$11.6B in 2023.

The data and analytics company noted that there is a growing market for better therapies to treat the condition given currently available treatments used as standard of care. Those include short- or long-acting beta-2 agonists, as well as muscarinic antagonists. Also, inhaled corticosteroids and phosphodiesterase inhibitors can be used as an add-on treatments.

“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),” said GlobalData Pharma Analyst Asiyah Nawab.

A biologic such as Dupixent could change that. Phase III results from two trials of the interleukin-4 and interleukin-13 inhibitor met their primary endpoints.

In the trials, Dupixent reduced moderate or severe acute COPD exacerbations by 30% and 34% over a year, as well as improved lung function at 12 weeks that was maintained through 52 weeks, compared to placebo. Sanofi (SNY) and Regeneron’s (REGN) sBLA for the drug as a COPD maintenance therapy has a U.S. FDA action date of June 27.

GlobalData noted that key opinion leaders they interviewed said they would be surprised if Dupixent did not get the green light.

But Dupixent isn’t the only new COPD treatment that could win FDA approval soon. In phase 3, Verona Pharma (VRNA) has ensifentrine, a dual PDE3/4 inhibitor that has also been backed by two successful late-stage trials. It has a June 23 FDA action date.

“The COPD space has not been in this (positive) position for decade,” Nawab wrote.