Verona Pharma has received the US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease (COPD).
The FDA has approved Ohtuvayre as a maintenance therapy for adult patients with the lung disease.
Ohtuvayre is said to be the first inhaled product in over two decades to feature a new mechanism of action.
The drug is a selective dual inhibitor targeting phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4). It combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule.
Ohtuvayre is administered directly to the lungs using a conventional jet nebuliser, which removes the need for high inspiratory flow rates or intricate hand-breath coordination.
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.”
The approval was based on data from the Phase 3 ENHANCE trials, which included the ENHANCE-1 and ENHANCE-2 studies.
Ohtuvayre met the primary endpoint in both studies and exhibited statistically significant and clinically meaningful improvements in lung function.
The maintenance therapy showed clinical benefits both alone and when used with other maintenance therapies.
Additionally, the drug demonstrated favourable tolerability across a diverse group of patients with moderate to severe COPD.
Verona Pharma plans to launch Ohtuvayre through an exclusive network of accredited speciality pharmacies.
The Nasdaq-listed biopharmaceutical company said that the drug also has the potential to treat non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases.
