The FDA has approved Verona Pharma’s first-in-class dual phosphodiesterase 3/4 inhibitor, Ohtuvayre (ensifentrine), for the US market. The asset is tailored towards patients with moderate to severe exacerbations with chronic obstructive pulmonary disease (COPD). The inhibitor has gained positive opinions from key opinion leaders (KOLs) due to its innovative mechanism of action, which permits a synergistic effect of both improved bronchodilation and decreased inflammation by targeting airway smooth muscles and airway inflammatory cells.
Several months before gaining approval, Verona Pharma’s inhibitor was able to provide promising evidence to the agency, showing a reduction in exacerbations in COPD patients. Alongside the company’s two successful Phase III clinical trials (ENHANCE-1 and ENHANCE-2), which were able to meet their primary endpoints, Verona’s presence at the 2024 American Thoracic Society (ATS) conference in May 2024 showed that Ohtuvayre was able to reduce exacerbation rate and risk over 24 weeks in COPD patients regardless of blood eosinophil levels compared to placebo, with significant differences seen in some subgroups of eosinophils (>100 and <300 cells/uL).
Additional data presented at the ATS conference showed that the candidate drug significantly improved dyspnea compared to placebo in as little as six weeks, and this was maintained over 24 weeks, measured by the Transition Dyspnea Index. At the end of 24 weeks, Ohtuvayre had clinically reduced dyspnea by 65%.
With funding of up to $650 million secured in 2024, Verona Pharma is well-positioned for the commercial rollout of Ohtuvayre in the US, ensuring its availability even beyond 2026. This funding aims to be spent on planned operating expenses, capital expenditure and its commercial launch now that the FDA has approved the asset in the US.
KOLs interviewed by GlobalData have shared optimistic views on Ohtuvayre, noting their own implementation and interest in using the asset for severe exacerbators due to the limited gastrointestinal side effects it presents, compared to other PDE inhibitors such as roflumilast. Despite some mixed opinions on the use of the nebulizer aspect of drug delivery, KOLs interviewed by GlobalData give a different opinion, stating that Ohtuvayre is easier to give to a COPD patient over biologics (currently found in the late-stage COPD pipeline) as these have not been marketed yet for COPD.
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By GlobalData