In a major development, the US Food and Drug Administration (FDA) has approved London based Verona Pharma's Ohtuvayre (ensifentrine) as a long-term treatment for people with chronic obstructive pulmonary disease (COPD),

For the first time in more than 20 years, a new type of COPD medication is now available for long-term use.

Ohtuvayre is known for having a unique way of acting on the body and providing relief to patients with COPD. A "first-in-class" drug, it goes after two enzymes, phosphodiesterase 3 and phosphodiesterase 4, which are involved in making the lungs swell and rest muscles. Ohtuvayre blocks these enzymes, which helps to clear out the lungs and reduce inflammation, making it easier to breathe.

While a normal nebulizer transforms liquid medicine into a mist and requires deep breathing, direct inhalation drugs don't require rapid breathing or complicated hand-breath coordination, which makes them easier for patients to use.

"The approval of Ohtuvayre marks a significant milestone in COPD therapy, and we believe Ohtuvayre's innovative profile has the potential to revolutionise COPD treatment," expressed David Zaccardelli, President and CEO of Verona Pharma. Ohtuvayre will be released in the third quarter of 2024 to help millions of COPD sufferers with daily symptoms.

An Associate Professor at the University of Alabama Birmingham named Dr. Michael Wells underlined how important this new treatment was, saying, "In my experience, despite maintenance therapy, most patients report dealing with everyday symptoms, such as shortness of breath and coughing all the time." In the United States, COPD has a big effect on both death and illness, and for more than 20 years, the only new ways to treat inhaled COPD have been combinations of standard therapy classes.

"Ohtuvayre, a first-in-class PDE3 and PDE4 inhibitor, provides a much-needed new approach and represents a significant advancement in the treatment of COPD," he added.

After considering the results of the Phase 3 ENHANCE trials in the American Journal of Respiratory and Critical Care Medicine, the FDA approved the drug. These trials demonstrated that Ohtuvayre had a lot of benefits, both by itself and when used with other maintenance treatments. Also, a wide range of people with moderate-to-severe COPD were able to handle it well.

Verona Pharma said that it intends to make Ohtuvayre available to patients in the third quarter of 2024.