Ivelin Radkov
Sanofi (NASDAQ: SNY) and Regeneron Pharmaeuticals (NASDAQ: REG) Dupixent (dupiliumab), already a blockbuster drug approved for several indications, including asthma and eosinophilic esophagitis, is poised for further advancements as it is likely to gain approval for chronic obstructive pulmonary disease.
Double sales might reach $21.4 billion worldwide by 2029, GlobalData predicts. The therapy led to global sales of approximately $11.6 billion 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. These include short- or long-acting beta-2 agonists, as well as muscarinic antagonists. Additionally, inhaled corticosteroids and phosphodiesterase inhibitors may be used as adjunctive treatments.
“These therapies are tolerable by patients; however, the progressive nature of COPD has created the need for additional maintenance therapy alongside [standard of care]”said Asiyah Nawab, pharmaceutical analyst at GlobalData.
A biologic like Dupixent could change that. Phase III results from two studies of interleukin-4 and interleukin-13 inhibitors met their primary endpoints.
In studies, Dupixent reduced moderate or severe COPD exacerbations by 30% and 34% over one year, as well as improved lung function at 12 weeks and maintained it for 52 weeks, compared to placebo. Sanofi’s (SNY) and Regeneron’s (REGN) sBLA for the drug as COPD maintenance therapy has a U.S. FDA action date of June 27.
GlobalData noted that key opinion leaders interviewed said they would be surprised if Dupixent didn’t get the green light.
But Dupixent isn’t the only new COPD treatment that could soon gain FDA approval. In Phase 3, Verona Pharma (VRNA) has ensifentrine, a dual PDE3/4 inhibitor that has also been supported by two successful late-stage clinical trials. The FDA action date is June 23.
“The space dedicated to COPD was not dedicated to this [positive] position for ten years,” Nawab wrote.