Both phase 3 pipeline agents were able to meet their trial endpoints and are to be used as maintenance or add-on therapies to the standard of care.
According to data and analytics firm GlobalData, this new wave of potential therapies will bring a shift in the treatment paradigm for COPD.
The company predicts total sales for Dupixent to reach $21.4 billion globally by 2029, and ensifentrine is forecast to record sales of $1.1 billion by 2029.
Asiyah Nawab, pharma analyst at GlobalData, said: “The standard of care (SoC) when treating COPD patients involves the use of either short- or long-acting beta-2 agonists or muscarinic antagonist as a monotherapy, or in combination.
“Alternatively, for exacerbators, the addition of inhaled corticosteroids (ICS) as a triple therapy regimen or taken alongside a long-acting beta agonist as a fixed-dose combination. Phosphodiesterase inhibitors (PDE) can be used as an add-on to triple therapy, depending on the severity of COPD.
“These therapies are tolerable by patients; however, the progressive nature of COPD has created a need for additional maintenance therapy alongside the SoC.”
The current gap in the COPD market can be attributed to the absence of biologics. However, Sanofi/Regeneron’s Dupixent, an interleukin-4 and interleukin-13 inhibitor, has the potential to address this gap, with positive results from two phase 3 clinical trials.
Nawab continues: “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.
“The positive results from both clinical trials led to FDA acceptance of Sanofi/Regeneron’s supplemental Biologics License Application (sBLA) as an add-on maintenance therapy and have set an FDA decision date for June 27, 2024. Key opinion leaders (KOLs) interviewed by GlobalData have expressed that Dupixent’s two trial endpoints are positive and would be surprised if there was a pushback in the FDA decision.”
In addition, Verona’s Ensifentrine, a first-in-class dual PDE3/4 inhibitor administered as a nebulized formulation, has also gained the FDA’s interest after two positive phase 3 trials met their primary endpoint of reducing exacerbations and improving lung function.
Nawab concludes: “The COPD late-stage market looks extremely promising, representing a shift in the treatment paradigm for COPD. The introduction of biologics and a novel ‘first-in-class’ dual phosphodiesterase inhibitor, given their positive clinical trial data, may lead to their penetration into the market this year. KOLs interviewed by GlobalData have expressed that the pipeline for COPD is extremely positive, with Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine having a high chance of being licensed, and that the COPD space has not been in this position for decades.”
