Verona's COPD drug Ohtuvayre clears FDA approval

The FDA has recently granted approval to Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults. This marks the first time in over 20 years that a new inhaled product with a novel mechanism of action has been approved for COPD maintenance therapy. Ohtuvayre is a dual PDE3/4 inhibitor that offers both bronchodilator and non-steroidal anti-inflammatory effects within a single molecule. This innovative approach may redefine how COPD is managed, according to Verona Pharma's CEO, David Zaccardelli. He described the approval as a “significant advance in COPD care” and expressed confidence in Ohtuvayre’s potential to transform the treatment landscape. Zaccardelli also mentioned that the company is preparing for a third-quarter launch.

The FDA's decision was influenced by the results from the Phase III ENHANCE trials, which showed that Ohtuvayre significantly improved lung function in COPD patients. The drug demonstrated clinical benefits not only as a standalone treatment but also when used alongside other maintenance therapies. Despite these positive outcomes, some key opinion leaders (KOLs) have expressed concerns about the study design, particularly the use of placebo as a comparator and the absence of endpoints to confirm the drug’s anti-inflammatory effects. These factors, they believe, might pose challenges in the commercial market.

One of the distinguishing characteristics of Ohtuvayre is its delivery system. The medication is administered directly to the lungs using a standard jet nebuliser. This method does not require patients to have high inspiratory flow rates or to coordinate their hand and breath, which can be difficult for some COPD patients using traditional inhalers. This ease of use could make Ohtuvayre accessible to a wider range of COPD patients, including those who have difficulty with conventional inhalers.

The approval of Ohtuvayre follows a significant financial agreement that Verona Pharma secured last month. The company entered into a deal with Oaktree Capital Management and OMERS Life Sciences for up to $650 million. This substantial funding package includes a $400-million debt facility and a $250 million revenue interest purchase and sale agreement (RIPSA). The funds are intended to support the launch of Ohtuvayre, ensuring that the company has the necessary resources to bring their new product to market effectively.

In summary, the FDA's approval of Ohtuvayre represents a major development in the treatment of COPD. With its unique dual PDE3/4 inhibition mechanism, Ohtuvayre combines bronchodilator and anti-inflammatory effects, potentially offering significant benefits to COPD patients. The utilization of a standard jet nebuliser for drug delivery enhances its accessibility, potentially extending its benefits to a broader patient population. However, despite the promising clinical trial results, some experts have raised concerns about the commercial challenges ahead. Nonetheless, with strong financial backing, Verona Pharma is well-positioned to introduce Ohtuvayre to the market, aiming to make a substantial impact on COPD treatment.