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.
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:Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy
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Source: Pharmaceutical Technology
FDA go-ahead for Verona Ohtuvayre transforms US COPD exacerbator market
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.
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