Verona Pharma Announces US FDA Nod of Ohtuvayre To Treat COPD

Verona Pharma plc, reports the US Food and Drug Administration ("FDA") approved Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (COPD) in grown-up patients. Since more than 20 years ago, Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD.

Ohtuvayre is a first-of-its-kind selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (also known as PDE3 and PDE4) that combines bronchodilator and a non-steroidal anti-inflammatory combines in a single molecule. A standard jet nebulizer delivers Ohtuvayre directly to the lungs without the need for complex hand-breath coordination or high inspiratory flow rates.

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

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD."