FDA Approval Boosts Verona's Ohtuvayre in COPD Market

Patients with chronic obstructive pulmonary disorder (COPD) in the U.S. now have access to a groundbreaking treatment, Ohtuvayre, thanks to the FDA's recent approval. This drug, developed by Verona Pharma, is the first of its kind to offer a novel mechanism of action for COPD in over a decade.

The approval of Ohtuvayre is a significant milestone, not just for the present but for its historical roots. This drug traces its origins back to Sir David Jack, a renowned pharmacologist who discovered its active compound, ensifentrine, nearly 40 years ago. Though initially known as RPL554 and struggling to gain traction after Jack's retirement, Verona Pharma has revived and refined the compound, culminating in Ohtuvayre's approval as the company’s first commercial product.

Ohtuvayre addresses the inflammatory condition of COPD, which severely restricts airflow and impairs breathing. It can be used as a standalone treatment or in conjunction with existing therapies. As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre uniquely combines properties that both open the airways and reduce inflammation in COPD patients.

David Zaccardelli, CEO of Verona Pharma, emphasized the drug's potential to revolutionize COPD treatment. “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” he explained, highlighting its dual bronchodilator and anti-inflammatory effects.

The administration of Ohtuvayre is also patient-friendly. It is given twice daily via a jet nebulizer, with each session lasting between five and seven minutes. Chris Martin, Chief Commercial Officer at Verona, pointed out that the method of administration should not hinder its adoption since many COPD patients are already familiar with nebulizers for chronic maintenance or rescue use.

Standard COPD treatments typically include inhaled corticosteroids and bronchodilators like long-acting beta agonists (LABAs) and long-acting muscarinic agonists (LAMAs). Some patients use all three, while others who cannot tolerate corticosteroids rely on a LAMA and LABA combination. The non-steroidal nature of Ohtuvayre makes it an appealing option for those wary of steroid treatments.

Two significant clinical trials, ENHANCE-I and ENHANCE-II, demonstrated Ohtuvayre's efficacy. The trials met their primary goals, showing improvements in lung function and a 40% reduction in flare-ups over 24 weeks in patients with moderate to severe COPD.

However, the cost of Ohtuvayre is notable. Verona has set the price at $2,950 per month, which translates to an annual cost of $35,400. This exceeds the cost-effectiveness thresholds established by the Institute for Clinical Economic Review (ICER), which range between $7,500 and $12,700 per year. Despite these cost concerns, the clinical data supports Ohtuvayre’s effectiveness and tolerability.

Verona plans to launch Ohtuvayre in the third quarter of this year, a strategic timing as they anticipate competition from Regeneron and Sanofi's Dupixent, which is also under FDA review for COPD treatment. Analysts project that while Dupixent could add a significant sales boost for Regeneron and Sanofi, Ohtuvayre is also expected to achieve blockbuster status, with sales reaching $1.05 billion by 2029.

The market for COPD treatments is vast, with 8.6 million patients in the U.S. alone and over 390 million people globally affected by the disease. The broad indication for Ohtuvayre allows physicians to consider it for a wide range of patients, especially those persistently symptomatic despite current therapies.

Looking ahead, Verona is also developing a fixed-dose combination of Ohtuvayre with the LAMA glycopyrrolate for COPD maintenance treatment. There are also potential applications for ensifentrine in treating other respiratory diseases like cystic fibrosis, non-cystic fibrosis bronchiectasis, and asthma.

With its FDA approval and substantial market potential, Verona Pharma could attract acquisition interest, possibly from major players like GSK, where ensifentrine originated under Sir David Jack's pioneering work. This development would bring the drug's journey full circle, back to the company that first explored its potential.