Clinical trial data submissions to the Food and Drug Administration (FDA) for Sanofi/Regeneron’s Dupixent and Verona’s Ensifentrine herald the introduction of novel therapies for chronic obstructive pulmonary disease (COPD) in 2024.
Both Phase III pipeline agents successfully met trial endpoints and are poised to serve as maintenance or add-on therapies to the standard of care.
Dupixent by Sanofi/Regeneron Bridges COPD Treatment Gap
Dupixent, an interleukin-4 and interleukin-13 inhibitor developed by Sanofi/Regeneron, demonstrates promise in addressing the existing gap in the COPD market. Positive results from two Phase III clinical trials, BOREAS and NOTUS, indicate its potential as a biologic intervention.
Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34% in the BOREAS and NOTUS trials, respectively, over 52 weeks compared to placebo (1✔ ✔Trusted Source
Dupixent® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
). Furthermore, it exhibited sustained improvement in lung function, leading to the FDA’s acceptance of Sanofi/Regeneron’s supplemental Biologics License Application (sBLA).
The FDA has set a decision date for June 27, 2024, reflecting the confidence expressed by Key Opinion Leaders (KOLs) interviewed by GlobalData in Dupixent’s positive trial outcomes.
Similarly, Verona’s Ensifentrine, a first-in-class dual PDE3/4 inhibitor administered via nebulized formulation, has garnered FDA interest following favorable outcomes from two positive Phase III trials, ENHANCE-1 and ENHANCE-2.
These trials met their primary endpoint of reducing exacerbations and improving lung function, positioning Ensifentrine as a promising addition to the COPD treatment landscape.
The late-stage COPD market holds significant promise, signaling a paradigm shift in COPD treatment. The introduction of biologics and novel dual phosphodiesterase inhibitors, driven by their positive clinical trial data, may usher in their market penetration this year.
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This optimism reflects a transformative phase for the COPD space, a rarity observed in decades.
Reference:
- Dupixent® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease – (https://www.sanofi.com/en/media-room/press-releases/2023/2023-11-27-06-30-00-2785836)
Source-Medindia
