David Mannino, MD

Mannino, Anzueto and Christenson conclude the panel with thoughts on developing biologics for COPD.

A Promising Pipeline for COPD

chronic obstructive pulmonary disease (COPD)

 drug development, panel moderator David Mannino, MD, chief medical officer of the COPD Foundation and professor at the University of Kentucky, discussed the short-term future of COPD drug research and development with panelists Antonio Anzueto, MD, professor of medicine and section chief of pulmonary at South Texas Veterans Healthcare System, and Stephanie Christenson, MD, associate professor of medicine at the University of California, San Francisco.

As the trio concluded discussion around the late-stage development and promising US Food and Drug Administration (FDA) applications for dupilumab (Dupixent) and ensifentrine (Ohtuvayre), they considered matters including a rekindled interest in novel drug development to treat the heterogenous, multifactorial and globally burdensome lower respiratory disease COPD. The advancement of dupilumab and ensifentrine to real-world COPD use aligns with similar targeted therapy progressions for other chronic respiratory diseases including cystic fibrosis, Mannino said.

Anzueto and Christenson additionally noted that at least another half-dozen biologic therapies are progressing in the COPD pipeline, with late-stage clinical data anticipated in the next 2-3 years. This may just be the beginning of a COPD therapy renaissance.

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

What the Ensifentrine FDA Approval Means for COPD

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.

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.

Videos

Mannino, Anzueto and Christenson conclude the panel with thoughts on developing biologics for COPD, and increased interest in the field after ensifentrine and dupilumab.

Ahead of the anticipated FDA decision in September, an expert panel reviews the promising data and unique role dupilumab may have in COPD.

Projecting Dupilumab's Fit in COPD

 drug development, panel moderator David Mannino, MD, chief medical officer of the COPD Foundation and professor at the University of Kentucky, discusses the supporting trial data for dupilumab (Dupixent) as a treatment for particular patients with COPD, with investigator Stephanie Christenson, MD, associate professor of medicine at the University of California, San Francisco.

The US Food and Drug Administration (FDA) is expected to rule on a supplemental application from Sanofi & Regeneron to indicate the interleukin 4 and 13 (IL-4; IL-13) inhibitor dupilumab as a treatment for adults with uncontrolled COPD and type 2 inflammation. Dupilumab, a preeminent biologic therapy in the utility of type 2 inflammatory disease management, was investigated by Christenson and colleagues in the pivotal BOREAS & NOTUS trials for COPD outcomes including exacerbation reduction versus maximum-standard triple-therapy inhaler medication.

Christenson and Mannino additionally discussed the role of type 2 inflammation in COPD pathophysiology and symptoms, what may be the practical utility of targeted biologics like dupilumab in the field, and the significance of achieving reduced COPD exacerbations with therapy.

Part 2: Projecting Dupilumab's Fit in COPD

Kunzmann K. FDA Extends Dupilumab COPD Decision to September 2024. 

. Published May 31, 2024. https://www.hcplive.com/view/fda-extends-dupilumab-copd-decision-september-2024

Campbell P. NOTUS Trial Confirms Dupixent Benefit in COPD with Type 2 Inflammation. 

. Published May 20, 2024. https://www.hcplive.com/view/notus-trial-confirms-dupixent-benefit-in-copd-with-type-2-inflammation

Smith T. Surya Bhatt, MD: Findings on Dupilumab for Patients with COPD, Type 2 Inflammation. 

. Published February 27, 2024. https://www.hcplive.com/view/surya-bhatt-findings-on-dupilumab-for-patients-with-copd-type-2-inflammation

In this HCPLive Special Report, experts review ensifentrine's role as a novel maintenance therapy for COPD.

 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.

 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.

Part 1: What the Ensifentrine FDA Approval Means for COPD

Kunzmann K. FDA Approves Ensifentrine (Ohtuvayre) for COPD. 

. Published June 26, 2024. https://www.hcplive.com/view/fda-approves-ensifentrine-for-copd

Kunzmann K. Ensifentrine Significantly Improves COPD Lung Function, Exacerbations. 

. Published August 9, 2022. https://www.hcplive.com/view/ensifentrine-significantly-improves-copd-lung-function-exacerbations

David Mannino, MD

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