The recent submission of clinical trial data for Sanofi/Regeneron’s Dupixent and Verona’s ensifentrine to the FDA indicates the entry of new therapies for COPD in 2024. Both phase III pipeline agents were able to meet their trial endpoints and are set to be used as maintenance or add-on therapies to the standard of care. GlobalData, a leading data and analytics company, said this new wave of potential therapies could change the way COPD is treated going forward.
GlobalData’s sales and forecast database is projecting total sales for Dupixent to reach $21.4 billion globally by 2029, while ensifentrine is projected to have sales of $1.1 billion by 2029.
“The standard of care when treating COPD patients involves the use of either short- or long-acting beta-2 agonists or muscarinic antagonist as a monotherapy,” said GlobalData pharma analyst Asiyah Nawab. “Alternatively, for exacerbators, the addition of inhaled corticosteroids (can be used) as a triple therapy regimen or taken alongside a long-acting beta agonist as a fixed-dose combination. Phosphodiesterase inhibitors can be used as an add-on to triple therapy, depending on the severity of the COPD. 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.”
That’s where biologics like Dupixent come in, filling a gap in COPD treatment created by the absence of biologics. Nawab said Dupixent, an interleukin-4 and interleukin-13 inhibitor, has the potential to address this gap based on the positive results reported in recent trials.
“The trials show that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% in the BOREAS trial and 34% in the NOTUS trial over 52 weeks, and improved lung function at 12 weeks that was sustained through 52 weeks, compared to placebo,” Nawab said. “The positive results from both clinical trials led to FDA acceptance of Sanofi/Regeneron’s supplemental biologics license application and have set an FDA decision date for June 27, 2024.”
As for ensifentrine, Nawab said the first-in-class dual PDE3/4 inhibitor administered as a nebulized formulation has also gained the FDA’s interest after two positive phase III trials met their primary endpoint of reducing exacerbations and improving lung function.
“Key opinion leaders interviewed by GlobalData have expressed that the pipeline for COPD is extremely positive, with Dupixent and ensifentrine having a high chance of being licensed, and that the COPD space has not been in this position for decades,” Nawab said.
