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. Verona Pharma logo

“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.

Mindy Hamlin, NCBiotech Writer
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