Verona Pharma Receives FDA Approval for Ohtuvayre

By Tamara Parker • Thursday, June 27 15:25 • Permanent Link

Verona Pharma PLC (NASDAQ: VRNA) has announced the US Food and Drug Administration (FDA) approval of Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

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. It is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

The company plans to launch Ohtuvayre in the third quarter of 2024, making it available to help the millions of patients who still experience daily COPD symptoms.

The US approval of Ohtuvayre was based on extensive data, including the phase 3 enhance trials, where Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. It was well-tolerated in a broad population of subjects with moderate to severe COPD.

Ohtuvayre met the primary endpoint in both enhance-1 and enhance-2, demonstrating statistically significant and clinically meaningful improvements in lung function. The company expects Ohtuvayre to be available in the third quarter of 2024 through an exclusive network of accredited specialty pharmacies.

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. It has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases.

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs, including COPD, non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma, and other respiratory diseases. As a result of these announcements, the company's shares have moved 4.3% on the market, and are now trading at a price of $15.32. Check out the company's full 8-K submission here.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.