Victory For Verona As FDA Approves Potential COPD Blockbuster

Verona Pharma plc's closely-watched chronic obstructive pulmonary disease (COPD) drug ensifentrine has made it over the line in the US, becoming the first inhaled product with a novel mechanism of action to be approved for the maintenance treatment of the respiratory disease in more than 20 years.

The drug, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor which combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, will be marketed as Ohtuvayre (pronounced oh-too-vare). The FDA's approval is based on data from the two Phase III ENHANCE trials, in which the therapy demonstrated improvements in lung function and substantially reduced the rate and risk of COPD exacerbations compared with placebo, regardless of blood eosinophil levels