Saturday, July 13, 2024

Chronic Obstructive Pulmonary Disease Treatment Revolution with FDA Approval of Verona Pharma’s Ohtuvayre

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Verona Pharma announced today that the US Food and Drug Administration (FDA) has approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. This marks a significant milestone as Ohtuvayre is the first inhaled product with a novel mechanism of action available for COPD maintenance treatment in over two decades.

Ohtuvayre is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), combining bronchodilator and non-steroidal anti-inflammatory effects in one molecule. It is administered via a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complex hand-breath coordination.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe its novel profile can change the treatment paradigm for chronic obstructive pulmonary disease,” said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter of 2024, ensuring it is available to help the millions of patients who still experience daily COPD symptoms.”

Ohtuvayre’s FDA Approval Marks Significant Advance in Chronic Obstructive Pulmonary Disease Treatment

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “Despite maintenance therapy, many patients struggle with daily symptoms such as breathlessness and persistent coughing. COPD significantly impacts both mortality and morbidity in the US. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a unique approach and is an important advance in chronic obstructive pulmonary disease treatment.”

The FDA approval of Ohtuvayre is based on extensive data from the Phase 3 ENHANCE trials, which were published in the American Journal of Respiratory and Critical Care Medicine. In these trials, Ohtuvayre demonstrated significant clinical benefits both as a standalone therapy and when used with other maintenance treatments. It was well-tolerated among a broad population of patients with moderate to severe chronic obstructive pulmonary disease.

Verona Pharma is fully staffed for the launch and expects Ohtuvayre to be available through an exclusive network of accredited specialty pharmacies in the third quarter of 2024.

Chronic Obstructive Pulmonary Disease

First Inhaled Therapy for Chronic Obstructive Pulmonary Disease with Dual Bronchodilator and Anti-Inflammatory Effects

Ohtuvayre is the first inhaled therapy for COPD maintenance that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. The Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel Inhaled Nebulized COPD Therapy”) demonstrated that Ohtuvayre significantly improves lung function. A fixed-dose combination of ensifentrine and glycopyrrolate (a LAMA) is under development for chronic obstructive pulmonary disease maintenance. Ensifentrine also has potential applications for non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases.

Ohtuvayre is prescribed for treating COPD in adults. It may cause serious side effects, including sudden breathing problems and mental health issues such as suicidal thoughts and behavior. It is not for treating sudden breathing problems and should not be used by individuals allergic to ensifentrine or its ingredients. Before using Ohtuvayre, patients should inform their healthcare provider if they have a history of mental health issues, or liver problems, are pregnant, or breastfeeding. The most common side effects include back pain, high blood pressure, bladder infection, and diarrhea.

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COPD includes diseases causing airflow blockage and breathing problems, affecting over 390 million people worldwide. Symptoms include breathlessness, frequent coughing, wheezing, chest tightness, and unusual tiredness. Despite available treatments, chronic obstructive pulmonary disease remains the third leading cause of death globally.

 

Resource: Verona Pharma, June 26, 2024

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