FDA Approves Ohtuvayre for COPD Maintenance Therapy

Verona Pharma has secured approval from the US Food and Drug Administration (FDA) for Ohtuvayre (ensifentrine), an inhaled maintenance treatment aimed at chronic obstructive pulmonary disease (COPD) in adults. Ohtuvayre is notable for its dual inhibition of phosphodiesterase 3 and 4 enzymes, offering both bronchodilator and non-steroidal anti-inflammatory benefits. Verona plans to introduce Ohtuvayre to the US market in the third quarter of this year.

The company is well-prepared for this launch, having secured funding up to $650 million, which ensures the availability of the treatment in the US market beyond 2026, according to Pharma Analyst Asiyah Nawab from GlobalData. This financial backing is set to facilitate the extensive distribution and accessibility of Ohtuvayre.

The FDA's approval of Ohtuvayre hinges on the positive outcomes from the Phase III ENHANCE-1 and ENHANCE-2 clinical trials. These studies, registered under NCT04535986 and NCT04542057, demonstrated significant improvements in COPD symptoms such as dyspnea, breathlessness, cough, sputum production, and chest discomfort in patients with moderate to severe COPD.

GlobalData projects that Ohtuvayre will achieve global sales of $1.1 billion by 2029. Its primary competitor in the market is Dupixent (dupilumab), a therapy developed by Sanofi and Regeneron Pharmaceuticals. Dupixent is currently pending FDA approval for another indication—targeting both interleukin-4 (IL-4) and interleukin-13 (IL-13)—expected to be decided in September. Dupixent has already been approved for multiple conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. This expansive range of uses is anticipated to drive Dupixent's global sales to $19.8 billion by 2029.

In addition to the US launch, Verona Pharma is looking to broaden the scope of Ohtuvayre's applications. The company intends to initiate a Phase II trial to evaluate Ohtuvayre for treating non-cystic fibrosis bronchiectasis—a chronic respiratory condition characterized by damaged bronchi due to recurrent infections and inflammation. Verona Pharma anticipates receiving FDA clearance to commence this trial in the latter half of this year.

Further expansion plans include a Phase II trial to assess Ohtuvayre as part of a fixed-dose combination treatment with glycopyrrolate, a long-acting muscarinic antagonist, for COPD maintenance therapy. Verona Pharma aims to submit an investigational new drug application (IND) for this combination treatment to the FDA in the second half of the year.

These strategic moves underscore Verona Pharma's commitment to enhancing treatment options for respiratory conditions and expanding the therapeutic potential of Ohtuvayre. As the company prepares for the US launch and additional clinical trials, the focus remains on delivering innovative treatments to meet the needs of patients with chronic respiratory diseases.