Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.
The FDA on Wednesday approved Verona Pharma’s ensifentrine—which will now carry the brand name Ohtuvayre—for the maintenance treatment of chronic obstructive pulmonary disease in adults.
Ohtuvayre is the first inhaled chronic obstructive pulmonary disease (COPD) treatment using a new mechanism of action in more than 20 years, according to Verona. The drug, a selective dual inhibitor of the PDE3 and four enzymes, elicits both bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is delivered via a jet nebulizer and works directly on the lungs.
Verona CEO David Zaccardelli in a statement called Ohtuvayre’s approval a “significant advance in COPD care,” claiming that the drug has the capability to “change the treatment paradigm for COPD.” The company expects to launch the COPD drug in the third quarter of 2024, “ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms,” Zaccardelli said.
The biotech is “fully staffed” for the launch of Ohtuvayre and can tap an “exclusive network of accredited specialty pharmacies,” according to Verona. Prior to the approval, Verona secured around $1 billion in financing to help with the drug’s rollout. In January 2024, the biotech signed a $400 million debt financing facility from Oxford Finance and Hercules Capital, which it replaced with an up to $650 million financing in May 2024, courtesy of Oaktree Capital Management and OMERS Life Sciences.
Verona has yet to disclose the pricing of Ohtuvayre. In May 2024, the Institute for Clinical and Economic Review found that the drug would satisfy common cost-effectiveness thresholds with an annual cost of $7,500 to $12,700.
Wednesday’s approval is backed by data from the Phase III ENHANCE-1 and ENHANCE-2 studies. Data from both studies were published in June 2023 in the American Journal of Respiratory and Critical Care Medicine, showing that Ohtuvayre can significantly improve lung function in COPD patients, resulting in an 87-mL and 94-mL improvement in forced expiratory volume in the respective trials.
Ohtuvayre also significantly reduced the rate of moderate or severe exacerbations, while prolonging the time before patients experienced their first exacerbation episode.
These findings position Ohtuvayre as a therapy that could help bring a “paradigm shift” to COPD care, according to a March 2024 report from analytics firm GlobalData. Its novel first-in-class dual-inhibitor mechanism could help it penetrate the market and lead to better outcomes for patients, according to the report.
“The COPD space has not been in this position for decades,” Asiyah Nawab, pharma analyst at GlobalData, said in a statement.
Targeting the COPD space is Sanofi and Regeneron’s blockbuster antibody Dupixent (dupilumab), which is currently being reviewed by the FDA. Last month, the regulator pushed back its target decision date for the biologic treatment to give it more time to analyze the treatment. The FDA’s new deadline is by Sept. 27, 2024.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
Correction (July 1): This story has been updated to clarify that Verona’s $650 debt facility in May 2024 replaced its previous $400 debt funding in January 2024. A previous version of this story wrongly stated that the two debt facilities were separate. BioSpace regrets the error.
