Verona Pharma plans to launch Ohtuvayre in the US in the third quarter of this year. Image Credit: rafapress / Shutterstock.

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients.

Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData.

GlobalData is the parent company of Pharmaceutical Technology.

The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD.

See Also:

Ohtuvayre is expected to generate global sales of $1.1bn by 2029, per a GlobalData analysis. The therapy’s major competitor is Sanofi and Regeneron Pharmaceutical’s blockbuster therapy Dupixent (dupilumab). The US FDA is set to decide on the approval of monoclonal antibody, that targets both interleukin-4 (IL-4) and interleukin-13 (IL-13), in September.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Dupixent has been approved for five other indications namely atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. Such broad use is expected to increase Dupixent sales, with the therapy expected to generate $19.8bn in global sales in 2029, as per GlobalData analysis.

Verona is also looking to expand the number of labelled indications for Ohtuvayre. The company plans to start a Phase II trial evaluating the therapy in patients with non-cystic fibrosis bronchiectasis, a respiratory condition where lung bronchi are damaged by repeated infections and inflammation. The company is expecting US FDA clearance to start the clinical trial, in the second half of this year.

The company also plans to start a Phase II trial evaluating Ohtuvayre as a fixed-dose combination treatment with a long-acting muscarinic antagonist, glycopyrrolate, as a maintenance therapy for COPD.  Verona intends to submit a related investigational new drug application (IND) to the FDA in the second half of this year.