Verona’s COPD Drug Ohtuvayre (ensifentrine) Gets FDA Nod

Verona’s COPD Drug Ohtuvayre (ensifentrine) Gets FDA Nod

More than 390 million people worldwide have COPD, and in the US, 8.6 million patients receive treatment for chronic symptoms of the condition.

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD).

COPD is a progressive lung disease that results in breathing problems, chronic coughs and fatigue. It includes conditions like emphysema and chronic bronchitis. According to the World Health Organization (WHO), COPD is the third leading cause of death worldwide with 3.23 million deaths in 2019 alone. More than 390 million people worldwide have COPD, and in the US, 8.6 million patients receive treatment for chronic symptoms of COPD.

Almost 90 percent of COPD deaths in individuals younger than 70 occur in low-income and middle-income countries. The WHO says tobacco smoking makes up more than 70 percent of COPD cases in high-income countries.

Conventional treatments to manage COPD include inhaled corticosteroids, which reduce inflammation, and bronchodilators, which widen the airways and relax muscles in the lungs. Bronchodilators include long-acting beta agonists (LABAs) and long-acting muscarinic agonists (LAMAs). Some COPD patients are on a regimen with all three treatments. Others, who can’t take corticosteroids, use a LAMA and LABA combo.

Ensifentrine is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), offering both bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The drug is delivered directly to the lungs via a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination, according to Verona.

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Ohtuvayre is administered twice daily with each session ranging from five minutes to seven minutes. Verona’s chief commercial officer, Chris Martin, said the company doesn’t expect the method of administration to significantly impact uptake, given that about half of COPD patients already use hand-held devices.

The journey to the approval was decades in the making, kickstarted by pharmacologist Sir David Jack who discovered ensifentrine 40 years ago while he was the R&D chief at GSK. The compound (RPL554) didn’t make it far. After Jack, Verona was established to take on ensifentrine and 19 years and almost 20 clinical trials later, the drug has finally received its approval. Ohtuvayre is the first commercial product for London-based Verona.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, president and chief executive officer of Verona Pharma.

The approval of Ohtuvayre was based on extensive data including two Phase III ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the trials, Ohtuvayre demonstrated clinical benefits both alone and in combination with other maintenance therapies in participants with moderate to severe COPD.

The trials met their primary endpoints where Ohtuvayre improved lung function. A pooled analysis of the two studies showed that Ohtuvayre reduced flare-ups by 40 percent through 24 weeks in patients with moderate to severe COPD.

The drug was shown to be most beneficial among patients who remain symptomatic after using a LAMA and LABA combination.

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Verona said it is “fully staffed to launch” and expects Ohtuvayre to be available in the third quarter of 2024 “through an exclusive network of accredited specialty pharmacies.”

Shanghai-based Nuance Pharma struck an agreement with Verona Pharma in 2021 for the exclusive rights to develop and commercialize ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). On April 6, 2023, Nuance Pharma announced dosing of the first patient for the ENHANCE-China Phase III clinical trial.

Verona shared that the list price of a monthly dose of Ohtuvayre will be $2,950, which comes out to $35,400 annually. The yearly price is beyond the cost-effectiveness threshold of $7,500 to $12,700 per year as determined by the Institute for Clinical Economic Review (ICER), which assesses the value of pharmaceuticals.

The COPD space is heating up this year as Regeneron and Sanofi are expected to nab a highly awaited approval for Dupixent (dupilumab) in COPD. The FDA pushed back its decision date three months to September 27 as the agency asked for more data from two trials supporting Dupixent’s approval.

Nevertheless, according to GlobalData, Ohtuvayre could become a blockbuster fairly quickly, with predicted sales reaching $1.05 billion by 2029.

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