There’s a new weapon in the arsenal of physicians and their patients with COPD. The U.S. Food and Drug Administration (FDA) has approved the use of ensifentrine as a maintenance treatment for adults with COPD.
Verona Pharma, which manufactures the drug under the brand name Ohtuvayre, said it is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. It is delivered directly to the lungs through a standard jet nebulizer without the need for high respiratory flow rates or complex hand-breath coordination.
“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 David Zaccardelli, PharmD, president and CEO of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”
Michael Wells, MD, associate professor in the division of pulmonary, allergy and critical care medicine at the University of Alabama Birmingham, said that despite maintenance therapy, most COPD patients report grappling with daily symptoms, including breathlessness and persistent coughing, and that he welcomes the new treatment.
“COPD has a significant impact on both mortality and morbidity in the U.S., and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades,” Dr. Wells said. “Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”
The FDA approval of Ohtuvayre was based on extensive data including the phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.
