Verona Gains FDA Nod for COPD Drug, Plans Q3 Launch with $1B Funding

The FDA has granted approval to Verona Pharma’s new drug, ensifentrine, now branded as Ohtuvayre, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. This approval marks the introduction of the first inhaled COPD treatment with a novel mechanism of action in over two decades. Ohtuvayre operates as a selective dual inhibitor of the PDE3 and PDE4 enzymes, providing both bronchodilator and non-steroidal anti-inflammatory benefits. The drug is administered directly to the lungs using a jet nebulizer.

David Zaccardelli, CEO of Verona Pharma, hailed the approval as a major advancement in COPD care, expressing confidence that Ohtuvayre has the potential to significantly alter the treatment landscape for this condition. Verona Pharma is preparing to launch the drug in the third quarter of 2024, aiming to benefit millions of patients who continue to suffer from daily COPD symptoms.

In preparation for the drug’s release, Verona has established a comprehensive launch strategy, including a fully staffed team and access to a network of accredited specialty pharmacies. The company has also secured substantial financial backing, amassing around $1 billion to support the rollout. This includes a $400 million debt financing agreement with Oxford Finance and Hercules Capital in January 2024, and an additional $650 million in funding arranged in May 2024 from Oaktree Capital Management and OMERS Life Sciences.

The pricing for Ohtuvayre has not yet been announced. However, a May 2024 analysis by the Institute for Clinical and Economic Review suggested that the drug would meet common cost-effectiveness standards if priced between $7,500 and $12,700 annually.

The FDA's decision to approve Ohtuvayre was supported by results from the Phase III ENHANCE-1 and ENHANCE-2 clinical trials. These studies, published in the American Journal of Respiratory and Critical Care Medicine, demonstrated that Ohtuvayre significantly enhances lung function in COPD patients. Specifically, the trials reported improvements of 87 mL and 94 mL in forced expiratory volume. Additionally, the drug was shown to reduce the frequency of moderate or severe exacerbations and extended the period before patients experienced their first exacerbation.

These promising results suggest that Ohtuvayre could serve as a transformative therapy in COPD care. According to a March 2024 report by GlobalData, the drug's unique dual-inhibitor mechanism positions it well for market penetration and improved patient outcomes. Asiyah Nawab, a pharma analyst at GlobalData, noted that the COPD treatment landscape has not seen such significant development in decades.

Meanwhile, the COPD treatment market is also anticipating the potential approval of Sanofi and Regeneron’s antibody treatment, Dupixent (dupilumab). The FDA is currently reviewing Dupixent and has extended its decision deadline to September 27, 2024, to allow for further analysis of the treatment.

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