27 Jun, 2024 FDA approval of Verona's Ohtuvayre to transform US COPD market for severe exacerbators, says GlobalData
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Following the Food and Drug Administration's (FDA) approval ofVerona Pharma's Ohtuvayre (ensifentrine) yesterday evening in the US:

Asiyah Nawab,Pharma Analyst atGlobalData, a leading data and analytics company, offers her view:

"Ohtuvayre, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, has great potential to dominate the market for moderate to severe exacerbators with chronic obstructive pulmonary disease (COPD). The innovative mechanism of this asset permits a synergistic effect of both improved bronchodilation and decreased inflammation because of targeting airway smooth muscles and airway inflammatory cells.

"After reviewing data from the 2024 American Thoracic Society (ATS) conference hosted in San Diego last month, Ohtuvayre was able to reduce exacerbation rate and risk over 24 weeks in COPD patients regardless of blood eosinophil levels compared to the placebo, with significant differences seen in some subgroups of eosinophils (>100 and <300 cells/uL). In addition to this, not only did the agent reduce exacerbation rate and risk, but the asset was able to tackle a significant symptom of COPD, dyspnea, which is prevalent in most COPD patients.

"With substantial funding of up to $650 million secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026. The key opinion leaders (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.

"Other KOLs have expressed enthusiasm for Ohtuvayre, primarily due to its novel target, emphasizing the significant value it brings. GlobalData's Sales and Forecast database projects total sales of Ohtuvayre to reach $1.1 billion globally by 2029. With the FDA approval of Ohtuvayre, as well as data presented at the 2024 ATS conference, it will be interesting to see the uptake of this asset in the COPD space, and perhaps for other respiratory conditions too."

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GlobalData plc published this content on 27 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 June 2024 04:33:06 UTC.