What the Ensifentrine FDA Approval Means for COPD

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EP: 1.What the Ensifentrine FDA Approval Means for COPD

EP: 2.Projecting Dupilumab's Fit in COPD

EP: 3.A Promising Pipeline for COPD

In the opening segment of this HCPLive Special Report – RX Reviews, Antonio Anzueto, MD, professor of medicine and section chief of pulmonary at South Texas Veterans Healthcare System, provides a review of the clinical trial data supporting ensifentrine (Ohtuvayre) as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

The US Food and Drug Administration (FDA) approved Verona Pharma’s application for ensifentrine on June 26—moments after the recording of this segment—on the basis of Anzueto and colleagues’ findings from the phase 3 ENHANCE trials.^1,2 The indication made ensifentrine the first COPD therapy with a novel mechanism of action approved by the FDA in more than a decade.

Here, Anzueto provides a detailed breakdown of the supporting clinical trial data for ensifentrine, as well as a review of its unique clinical benefit as an inhaled, nonsteroidal, dual inhibitor of the dual inhibitor of the phosphodiesterase 3 and 4 (PDE3; PDE4) pathways. Additionally, he and panel moderator David M. Mannino, MD, chief medical officer of the COPD Foundation and professor at the University of Kentucky, discuss the current state drug development in COPD, and what impact the FDA approval of ensifentrine may have on clinicians and their patients.

Check out the entire 3-part Special Report series, ‘COPD: New Therapy Breakthroughs’:

Part 1: What the Ensifentrine FDA Approval Means for COPD

Part 2: Projecting Dupilumab's Fit in COPD

Part 3: A Promising Pipeline for COPD

Our Moderator:

David M. Mannino, MD, Chief Medical Officer and Co-Founder of the COPD Foundation, and Professor of Internal Medicine, Pulmonary, Critical Care and Sleep Medicine at the University of Kentucky.

Our Panelists:

Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System.

Stephanie Christenson, MD, Associate Professor of Medicine, Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine at University of California, San Francisco.

References

1. ^{Kunzmann K. FDA Approves Ensifentrine (Ohtuvayre) for COPD. HCPLive. Published June 26, 2024. https://www.hcplive.com/view/fda-approves-ensifentrine-for-copd}
2. ^{Kunzmann K. Ensifentrine Significantly Improves COPD Lung Function, Exacerbations. HCPLive. Published August 9, 2022. https://www.hcplive.com/view/ensifentrine-significantly-improves-copd-lung-function-exacerbations}