• 01 Jul 2024
• Admin
• News Article

Verona Pharma Gets US FDA Approval for Ohtuvayre to Treat COPD

Verona Pharma gets US FDA approval for Ohtuvayre for maintenance treatment of COPD in adult patients in more than 20 years

Overview

Ligand Pharmaceuticals Inc, a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines, announced its partner Verona Pharma plc has received approval from the US Food and Drug Administration (FDA) for Ohtuvayre (ensifentrine). Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients in more than 20 years. Ligand has earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre.

Words from CEO: Ligand

• “Verona Pharma has worked tirelessly to bring a new treatment option to the millions of people managing chronic COPD and we are excited to see their efforts come to fruition with this approval,” said Todd Davis, CEO of Ligand. 
• “For Ligand this is an important milestone, as it’s the second US FDA approval within our royalty portfolio in two weeks and the eighth regulatory approval since 2023. COPD is a multi-billion-dollar market opportunity in the US alone, and we believe Ohtuvayre will be another key growth driver for Ligand.”

About Ohtuvayre

• Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. 
• Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

Post FDA Approval

With this US FDA approval, Ligand now has 11 key commercial products driving the company’s financial performance and a portfolio of more than 100 additional programmes at various stages of development.

Ohtuvayre for COPD

• Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. 
• Verona has evaluated nebulized Ohtuvayre in its phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) for COPD maintenance treatment. 
• Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. 
• A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. 
• Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

Chronic Obstructive Pulmonary Disease

• Chronic obstructive pulmonary disease (COPD) refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis. 
• More than 390 million people worldwide are living with COPD, and more than 8.6 million Americans are treated chronically. 
• Symptoms include increased shortness of breath, frequent coughing (with and without mucus), wheezing, tightness in the chest and unusual tiredness. 
• Approximately 50% of COPD patients experience almost daily symptoms. 
• There is no cure for COPD and despite available treatment options, it is the third leading cause of death globally.