Revolutionary COPD treatment: FDA approves Verona Pharma’s Ohtuvayre - sales to hit $1.1BN by 2029

27-Jun-2024 - Last updated on 27-Jun-2024 at 10:58 GMT

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine), marking a significant milestone in the treatment of chronic obstructive pulmonary disease (COPD).

This groundbreaking approval is expected to transform the market for patients suffering from moderate to severe exacerbations, particularly those with limited treatment options.

Asiyah Nawab, a Pharma Analyst at GlobalData, provides her expert insights on the approval and its implications. "Ohtuvayre, a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor, has great potential to dominate the market for moderate to severe exacerbators with COPD," she said. "The innovative mechanism of this asset permits a synergistic effect of both improved bronchodilation and decreased inflammation by targeting airway smooth muscles and airway inflammatory cells."

At the 2024 American Thoracic Society (ATS) conference in San Diego, Ohtuvayre demonstrated its efficacy in reducing exacerbation rates and risks over 24 weeks in COPD patients, irrespective of blood eosinophil levels. Significant improvements were observed in certain eosinophil subgroups (>100 and <300 cells/uL), with the drug also effectively alleviating dyspnea, a common and debilitating symptom of COPD.

Funding totaling up to $650 million

Verona Pharma has secured substantial funding, totaling up to $650 million, to support the US distribution of Ohtuvayre. This financial backing ensures the drug's availability well beyond 2026, positioning Verona Pharma to meet the anticipated high demand. Nawab notes, "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."

KOLs have expressed particular enthusiasm for Ohtuvayre due to its novel target and the significant value it brings to the COPD treatment landscape. GlobalData’s Sales and Forecast database projects that total sales of Ohtuvayre could reach $1.1 billion globally by 2029. The approval and positive data from the 2024 ATS conference have set the stage for widespread adoption of this innovative therapy, potentially extending its use to other respiratory conditions in the future.

The FDA approval of Ohtuvayre represents a major leap forward in COPD treatment, offering new hope to patients who struggle with severe exacerbations. The combination of its novel mechanism, substantial financial backing, and strong endorsement from KOLs positions Ohtuvayre as a game-changer in the COPD market. As Verona Pharma moves forward with the distribution of Ohtuvayre, the biopharmaceutical community will be watching closely to see the impact of this breakthrough treatment on the lives of COPD patients and beyond.