The FDA approved Verona Pharma’s drug for chronic obstructive pulmonary disease, or COPD, the first maintenance treatment with a new mechanism for the ailment in over two decades, according to the company.
Ensifentrine was approved for adult COPD patients and will be marketed as Ohtuvayre. The company didn’t immediately disclose Ohtuvayre’s list price.
Verona is now entering an arena with pharmaceutical goliaths like GSK and AstraZeneca, though the company’s executives say that it’s not competing head-to-head. Rather, Verona believes it can carve out a niche as an add-on treatment for patients who aren’t well-served by existing therapies.
“We really don’t need to compete in the sense of displacing other drugs,” Verona CEO David Zaccardelli said in an interview before the approval. “Ensifentrine can be added to patients who are on standard therapy, currently symptomatic and need additional help.”
Verona’s drug is taken via a nebulizer twice a day and can be given on top of standard therapies like inhalers and inhaled corticosteroids. In two Phase 3 clinical trials, participants who received ensifentrine did better on a breathing test at 12 weeks compared with those who received placebo, and those results were consistent across patients taking different background therapies.
Jefferies analysts project peak sales of $1 billion by 2031 for Ohtuvayre.
In May, Verona inked a $650 million financing deal to support its launch efforts that the analysts said reinforced the idea that Verona isn’t selling to a pharma company anytime soon — a common fate for late-stage drug developers entering larger commercial markets.
“We don’t structure our behaviors or our business around M&A and those types of activities. Our approach is always to run the business to make sure if we are financed properly, that we are resourced properly, that we execute, across development, commercialization, all of that,” Zaccardelli said. “M&A happens as it will. We don’t control that side of the business.”
The FDA is also expected to decide whether to approve Regeneron’s Dupixent for COPD by September 27.
Editor’s note: This story has been updated to correct the FDA decision date for Dupixent.