Verona Pharma plc (Nasdaq: VRNA) announced that the U.S. Food and Drug Administration (FDA) has approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. This is the first inhaled product with a novel mechanism of action approved for COPD maintenance 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 a single molecule. It is administered directly to the lungs 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," said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. "We plan to launch Ohtuvayre in the third quarter of 2024, making it available to help millions of patients who experience daily COPD symptoms."

Dr. Michael Wells, Associate Professor at the University of Alabama Birmingham, added, "COPD significantly impacts mortality and morbidity in the U.S., and innovation in inhaled treatments has been limited for over two decades. Ohtuvayre offers a unique approach and is an important advance in treatment."

The FDA approval was based on extensive data from the Phase 3 ENHANCE trials, which were published in the American Journal of Respiratory and Critical Care Medicine. The trials showed that Ohtuvayre provided clinical benefits both alone and alongside other maintenance therapies and was well-tolerated among subjects with moderate to severe COPD.

Verona Pharma is prepared to launch Ohtuvayre in the third quarter of 2024 through an exclusive network of accredited specialty pharmacies.

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for COPD maintenance that combines bronchodilator and non-steroidal anti-inflammatory activities. It demonstrated significant improvements in lung function in the ENHANCE-1 and ENHANCE-2 trials. Verona Pharma is also developing a fixed-dose combination of ensifentrine and glycopyrrolate for COPD treatment and exploring its potential for other respiratory diseases like asthma and cystic fibrosis.

Safety Information

Ohtuvayre can cause serious side effects, including sudden breathing problems and mental health issues such as suicidal thoughts and behavior. It is not suitable for those allergic to ensifentrine or any of its ingredients. Common side effects include back pain, high blood pressure, bladder infections, and diarrhea. Always consult a healthcare provider before using Ohtuvayre, especially if you have a history of mental health problems, liver issues, or are pregnant or breastfeeding.

For detailed safety information and to report side effects, visit the FDA's MedWatch website or call 1-800-FDA-1088.

COPD is a chronic lung disease causing airflow blockage and breathing issues, affecting over 390 million people globally. Despite existing treatments, it remains the third leading cause of death worldwide, with many patients experiencing daily symptoms like breathlessness, coughing, and chest tightness.