US FDA New Drug Application Approval of Ohtuvayre™ (ensifentrine) for the Maintenance Treatment of COPD

SHANGHAI, June 27, 2024 /PRNewswire/ -- Nuance Pharma's global partner Verona Pharma plc (Nasdaq: VRNA), announces the US Food and Drug Administration ("FDA") approved 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. 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.

The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD. 

"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," said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. "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."

Mr. Mark Lotter, founder and CEO of Nuance Pharma, commented: "We are pleased to see ensifentrine's approval with FDA and the planned commercial launch in the US, and we are excited about ensifentrine's potential to re-define the COPD treatment globally as the first-in-class novel therapy. With the largest patient pool globally, COPD in China represents significant disease burden for the public, we are committed to bringing this first-in-class therapy to patients in Greater China as soon as possible, through propelling the ENHANCE-China Phase 3 clinical study, as well as a range of early access programs in the region. Today marks an important milestone for the molecule, we are excited about the potential in expanding opportunities including new indications."

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). On April 6th 2023, Nuance Pharma announced dosing of first patient for the ENHANCE-China Phase 3 clinical trial.

About Ohtuvayre (ensifentrine)

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. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

About Verona Pharma

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. For more information, please visit www.veronapharma.com. 

About Nuance pharma

Nuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia. With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com. 

Forward-Looking Statements

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

source: Nuance Pharma Limited