Verona says COPD drug is off to a flying start
Verona Pharma has blockbuster hopes for its recently approved drug for chronic obstructive pulmonary disorder (COPD), and preliminary sales figures for the drug suggest it is heading in the right direction.
The company bagged FDA approval for first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor Ohtuvayre (ensifentrine) last June, becoming the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, and launched a few weeks later.
Third-quarter sales of $6 million came in well ahead of analyst expectations, despite a short period on the market, and now Verona has revealed the drug made approximately $36 million in the final three months of 2024, off more than 16,000 prescriptions.
Chief executive David Zaccardelli said Ohtuvayre was off to an "exceptionally strong start," with more than 3,500 healthcare professionals prescribing the drug, accounting for around 45% of the 'tier 1' physicians recognised as specialists in COPD.
During its first 20 weeks on the market, there has been steady growth in the number of unique prescribers, new patient prescriptions, refill prescriptions, and net sales, he added, with filled prescriptions increasing by more than a third each month in the fourth quarter.
In the phase 3 ENHANCE trials, Ohtuvayre 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.
The drug provides both bronchodilation and anti-inflammatory properties in a single molecule and is administered using a jet nebuliser that is suitable for patients who may have limited capacity to use regular inhalers.
That profile has led analysts at GlobalData to predict sales could reach around $1.1 billion at peak, fuelled by strong take-up in patients who are prone to exacerbations – the sudden flare-ups in symptoms that signpost the relentless progression of COPD.
Zaccardelli said the prescribing and sales trends "reinforce [...] belief that Ohtuvayre's bronchodilator and non-steroidal anti-inflammatory activity can re-define the COPD treatment paradigm."
The encouraging sales figures come at a time when treatment options for COPD patients have started to increase after years of stagnation.
In July, the European Commission became the first regulator worldwide to approve Sanofi and Regeneron's big-selling IL-4 and IL-13 inhibitor Dupixent (dupilumab) as a treatment for the lung disease, which was followed by green lights in the US and China.
GSK's IL-5 inhibitor Nucala (mepolizumab) could also be heading for approval in COPD – at the second attempt – after reducing exacerbations in the phase 3 MATINEE trial, while Amgen and AstraZeneca have said their anti-TSLP-antibody Tezspire (tezepelumab) is also a contender after a phase 2a readout.
Photo by Brett Jordan on Unsplash
