FDA Gives Thumbs Up to Verona Pharma's Advanced Inhaled COPD Therapy

The U.S. Food and Drug Administration has approved Verona Pharma's new treatment for a chronic lung disease often seen in smokers, the U.K.-based company announced on Wednesday. Following the approval, the company's U.S.-listed shares jumped 11% in after-hours trading. The FDA's approval of the therapy, branded as Ohtuvayre, marks Verona's first approved product and introduces a novel inhaled non-steroidal treatment for chronic obstructive pulmonary disease (COPD).

COPD is a long-term condition that leads to restricted airflow and breathing difficulties, commonly linked to cigarette smoking and also known as "smoker's lungs." Other risk factors include exposure to fumes, chemicals, and dust in various workplaces. Affecting about 16 million Americans, COPD is the sixth leading cause of death in the U.S., according to government statistics. Verona's approval was based on efficacy and safety data from two late-stage trials, where Ohtuvayre showed significant improvements in lung function and symptoms, and notably reduced the risk of exacerbations in patients with mild to severe COPD.

The therapy is a single-drug treatment aimed at relaxing the muscles around the airways to improve breathing. It also reduces lung inflammation without the use of steroids. Chief Commercial Officer Christopher Martin told Reuters ahead of the FDA decision that the company anticipates having approximately 100 sales representatives to target around 15,000 physicians and is confident in its ability to achieve this if approval is granted. The company also announced plans to reveal pricing details during an investor conference call on Thursday.