FDA Approves Verona Pharma's Novel Ohtuvayre™ (ensifentrine) for COPD Maintenance
Ligand Pharmaceuticals has announced that its partner, Verona Pharma has gained approval from the U.S. Food and Drug Administration for Ohtuvayre™ (ensifentrine).
This product is the first inhaled treatment with a novel mechanism of action for the maintenance of chronic obstructive pulmonary disease (COPD) in adults in over 20 years.
Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that integrates bronchodilator and non-steroidal anti-inflammatory actions in one molecule. Verona Pharma has tested nebulised Ohtuvayre in its Phase 3 clinical programme ENHANCE, which demonstrated statistically significant improvements in lung function in both ENHANCE-1 and ENHANCE-2 trials.
A fixed-dose combination of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), is also in development for COPD maintenance treatment. Furthermore, ensifentrine has potential applications in the treatment of non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases.
Ohtuvayre is a selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4) enzymes, offering both bronchodilator and non-steroidal anti-inflammatory effects in a single molecule.
It is delivered directly to the lungs using a standard jet nebulizer, eliminating the need for high inspiratory flow rates or complicated hand-breath coordination.
