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news.The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.
The US approval of Ohtuvayre was based on extensive data including the Phase III ENHANCE trials. Credit: Robina Weermeijer on Unsplash.
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Ohtuvayre is claimed to be the first inhaled medication with a unique mechanism of action for COPD maintenance therapy in more than two decades.
A dual inhibitor of the phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4) enzymes, the product possesses both bronchodilator and non-steroidal anti-inflammatory effects in a single molecule.
Ohtuvayre is administered directly to the lungs using a conventional jet nebuliser, eliminating the requirement of increased inspiratory flow rates or intricate hand-breath synchronisation.
The US clearance of Ohtuvayre was based on comprehensive evidence, including the Phase III ENHANCE studies.
In the ENHANCE studies, the therapy showed therapeutic advantages both as monotherapy and in combination with other maintenance treatments.
Ohtuvayre was also well tolerated in a large number of individuals with moderate to severe disease.
The product will be offered through an exclusive network of authorised specialty pharmacies in the third quarter of this year.
Ohtuvayre demonstrated statistically significant and clinically meaningful improvements in lung function, meeting the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials.
For the maintenance therapy of COPD, a fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is presently being developed.
Applications for ensifentrine may be developed for respiratory disorders such as asthma, bronchiectasis, cystic fibrosis, and non-CF.
Verona Pharma president and CEO David Zaccardelli said: “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.
“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.”
