FDA Approves Ohtuvayre for Adult COPD Maintenance

The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) to be used as a maintenance treatment for adults suffering from chronic obstructive pulmonary disease (COPD). COPD affects over 390 million individuals globally, and is characterized by airflow obstruction and breathing difficulties. Despite the existing treatments, COPD remains the third leading cause of death worldwide, with nearly half of the patients experiencing daily symptoms like shortness of breath, frequent coughing, and wheezing.

Ohtuvayre distinguishes itself as the first inhaled therapy for COPD maintenance that combines both bronchodilator and non-steroidal anti-inflammatory properties in a single molecule. It is a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4. The medication is administered directly to the lungs using a standard jet nebulizer, which does not require high inspiratory flow rates or complex hand-breath coordination.

The approval from the FDA was supported by data from the late-stage ENHANCE trials, where Ohtuvayre demonstrated clinical benefits both as a standalone therapy and in combination with other maintenance treatments. The drug met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials, showing statistically significant improvements in lung function across primary and secondary endpoints.

David Zaccardelli, the president and CEO of Verona, remarked that the approval of Ohtuvayre marks a significant advancement in the treatment of COPD. He expressed confidence in the drug’s ability to change the treatment landscape for COPD due to its novel characteristics. Zaccardelli also revealed plans to launch Ohtuvayre in the third quarter of 2024, aiming to make the therapy available to millions of patients who continue to suffer from daily COPD symptoms.

Michael Wells, an associate professor in the division of pulmonary, allergy, and critical care medicine at the University of Alabama Birmingham, also commented on the FDA’s decision. He highlighted the substantial impact of COPD on mortality and morbidity in the US, noting that innovative inhaled treatments have been limited over the past two decades to combinations of existing therapies. Wells stated that Ohtuvayre offers a much-needed unique approach and represents an important advancement in COPD treatment.

In addition to treating COPD, Verona has indicated that Ohtuvayre may have potential applications for other respiratory conditions, including non-cystic fibrosis bronchiectasis, cystic fibrosis, and asthma.