The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvere (ensifantrine) as a maintenance treatment for adults with chronic obstructive pulmonary disease (COPD).
COPD affects more than 390 million people worldwide, including a variety of conditions that obstruct airflow and cause respiratory difficulties.
Despite existing treatment options, COPD is the third leading global cause of death, with nearly half of patients experiencing symptoms such as shortness of breath, frequent coughing and wheezing on a daily basis.
Ohtuvere represents a breakthrough as the first inhaled therapy for COPD maintenance that combines bronchodilator and non-steroidal anti-inflammatory properties within a single molecule. It acts as a selective dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes.
The therapy is administered directly into the lungs via a standard jet nebulizer, requiring neither high respiratory flow rates nor complex hand-breath coordination.
Key evidence supporting FDA approval includes findings from the ADVANCED ENHANCE trials, where Ohtuvere demonstrated clinical benefits both as a standalone treatment and in combination with other maintenance therapies.
Ohtuvare achieved primary endpoint success in both ENHANCE-1 and ENHANCE-2, showing statistically significant improvements in lung function across primary and secondary measures.
Davide Jaccardelli, President and CEO of Verona, commented, “The approval of Ohtuvere represents an important milestone in COPD management, and we believe its unique features could revolutionize COPD treatment.”
Zaccardelli confirmed the company’s intention to launch Ohtuvere in the third quarter of 2024, thereby “ensuring access for the millions of patients who continue to suffer daily COPD symptoms.”
Offering his perspective on the FDA’s decision, Michael Wells, MD, an associate professor specializing in pulmonary, allergy and critical care medicine at the University of Alabama Birmingham, commented, “COPD significantly impacts both mortality and morbidity in the US, and “So far, innovative inhaled treatment options have been limited to combinations of classes existing for more than two decades.”
He added, “Ohtuvere…offers a much-needed, unique approach and represents a significant advancement in COPD treatment.”
Verona also highlighted Ohtuvere’s potential beyond COPD, noting its applicability to other respiratory conditions such as non-cystic fibrosis bronchiectasis, cystic fibrosis and asthma.
FDA
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