Verona’s first-in-class COPD drug ‘could transform market’

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.

The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to Verona.

GlobalData has suggested that Ohtuvayre could have a transformative role to play in the management of COPD patients who are prone to exacerbations, sudden flare-ups in symptoms that signal the progression of the disease.

In its phase 3 ENHANCE programme, the drug was shown to reduce exacerbation rate and risk over 24 weeks in COPD patients, regardless of blood eosinophil levels, compared to placebo, and also improve lung function scores.

Its mechanism means that it provides both bronchodilation and anti-inflammatory properties in one molecule, and is administered using a jet nebuliser that is suitable for patients who may have limited capacity to use regular inhalers.

Ohtuvayre is due to launch in the US in the third quarter of this year, assisted by a $650 million debt facility that Verona agreed a few months ago to build its commercial capabilities. The company said it is now “fully staffed to launch” the new product in the US through a network of accredited specialty pharmacies, but has not yet revealed its price.

“Key opinion leaders (KOLs) interviewed by GlobalData have shared optimistic views on Ohtuvayre, noting their own implementation and interest in using the asset for severe exacerbators due to the limited gastrointestinal side effects it presents, compared to other PDE inhibitors,” said pharma analyst Asiyah Nawab.

She pointed to the drug’s efficacy against dyspnoea or shortness of breath, which is prevalent in COPD patients and one of its most debilitating symptoms. GlobalData is predicting that worldwide sales of Ohtuvayre could top $1.1 billion by 2029.

Dupixent up next

There could be another important new product approved by the FDA later this year, as the regulator is due to deliver its verdict on a COPD indication for Sanofi and Regeneron’s big-selling IL-4 and IL-13 inhibitor Dupixent (dupilumab) in September, after a three-month delay caused by a request for more data. It was recommended for approval in the EU last month.

COPD is the third leading cause of death worldwide, killing more than three million people in 2019, according to World Health Organization (WHO) estimates. The massive number of patients with the disease has led some analysts to predict that Dupixent could see sales of $3.5 billion from that indication alone.

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