The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for adults with chronic obstructive pulmonary disease (COPD).
More than 390 million people worldwide are living with COPD, a group of diseases that cause airflow blockage and breathing-related problems.
Despite available treatment options, COPD is the third leading cause of death globally, and approximately half of patients experience almost daily symptoms, including increased shortness of breath, frequent coughing and wheezing.
Ohtuvayre is a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 and is now the first inhaled therapy for COPD maintenance treatment that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
The therapy is delivered directly to the lungs through a standard jet nebuliser without the need for high inspiratory flow rates or complex hand-breath coordination.
Among the data supporting the FDA’s approval are results from the late-stage ENHANCE trials, in which Ohtuvayre was associated with clinical benefits as both a monotherapy and when used with other maintenance therapies.
Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant improvements in lung function across both primary and secondary endpoints.
David Zaccardelli, Verona’s president and chief executive officer, said: “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.”
Zaccardelli added that the company plans to launch Ohtuvayre in the third quarter of 2024, ensuring the therapy is “available to help the millions of patients who still experience daily COPD symptoms”.
Also commenting on the FDA’s decision, Michael Wells, associate professor in the division of pulmonary, allergy and critical care medicine at the University of Alabama Birmingham, said: “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… offers a needed, unique approach and is an important advance in the treatment of COPD.”
Beyond COPD, Verona outlined that Ohtuvayre has potential applications in other respiratory diseases, including non-cystic fibrosis bronchiectasis, cystic fibrosis and asthma.