Verona Pharma receives FDA approval for first inhaled COPD treatment
Verona Pharma announced it has received FDA approval for Ohtuvayre (Ensifentrine), a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. It is the first inhaled product available for the disease and is delivered directly to the lungs through a standard jet nebulizer.
The U.K clinical-stage biotech firm with U.S. headquarters in Raleigh also announced it will take the treatment to market in the third quarter of this year. 
“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 Verona Pharma President and CEO David Zaccardelli in a statement. “We plan to launch Ohtuvayre in the third quarter of 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”
The treatment is a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule.
FDA approval of Ohtuvayre came after Verona completed its Phase 3 ENHANCE (Ensifentrine as a Novel inhaled Nebulized COPD thErapy) trials. In its clinical trials, the company found that the treatment was “well-tolerated” among subjects with moderate to severe COPD.
The company is also investigating the potential of Ensifentrine in treatment the treatment of non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.
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