Verona Pharma Receives FDA Approval for Ohtuvayre™ (ensifentrine)

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

Ohtuvayre stands out as a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4), integrating bronchodilator and non-steroidal anti-inflammatory effects within a single molecule. This innovative medication is administered directly to the lungs via a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complex hand-breath coordination.

David Zaccardelli, President and CEO of Verona Pharma, remarked, "The approval of Ohtuvayre represents a significant advance in COPD care. We believe Ohtuvayre’s novel profile will change the treatment paradigm for COPD. We plan to launch Ohtuvayre in the third quarter of 2024, making it available to the millions of patients who continue to experience daily COPD symptoms."

Dr. Michael Wells, an Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, shared his insights: "Despite maintenance therapies, most COPD patients continue to struggle with daily symptoms such as breathlessness and persistent coughing. COPD significantly impacts both mortality and morbidity in the US, and innovation in inhaled treatment modalities has been stagnant for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a unique and much-needed approach to COPD treatment."

The FDA's approval of Ohtuvayre was supported by extensive data, including results from the Phase 3 ENHANCE trials published in the American Journal of Respiratory and Critical Care Medicine. These trials demonstrated that Ohtuvayre provided clinical benefits both as a standalone treatment and when used alongside other maintenance therapies. The medication was well-tolerated among a wide range of patients with moderate to severe COPD.

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

Ohtuvayre (ensifentrine) is a groundbreaking inhaled therapy for COPD maintenance that uniquely combines bronchodilator and non-steroidal anti-inflammatory effects. Verona Pharma has conducted extensive research on nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE, achieving statistically significant and clinically meaningful improvements in lung function. Additionally, a fixed-dose combination of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), is under development for COPD maintenance. Ensifentrine also shows potential for treating non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases.

Ohtuvayre is prescribed for adult COPD patients and is not intended for acute breathing problems. It is crucial to have a rescue inhaler available for sudden breathing issues. Patients should be aware of potential serious side effects, including sudden breathing problems and mental health issues such as suicidal thoughts and behavior. Common side effects include back pain, high blood pressure, bladder infections, and diarrhea. Patients should inform their healthcare provider about their complete medical history and current medications before starting Ohtuvayre.

Chronic obstructive pulmonary disease (COPD) encompasses a group of diseases that cause airflow obstruction and breathing issues, including emphysema and chronic bronchitis. Globally, over 390 million people live with COPD, with more than 8.6 million Americans receiving ongoing treatment. Symptoms often include shortness of breath, frequent coughing, wheezing, chest tightness, and unusual fatigue. COPD remains incurable and is the third leading cause of death worldwide despite available treatments.

Verona Pharma is dedicated to developing and commercializing innovative therapies for chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, and asthma.