Pharmaceutical Technology

Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

Ohtuvaye is expected to rake in $1.1bn in global sales from the market for COPD patients with moderate to severe exacerbations by 2029.

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.

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.

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.

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.