Verona secures FDA approval for COPD treatment

The U.S. FDA has granted approval for Verona Pharma's inhaled nonsteroidal nebulizer therapy, branded as Ohtuvayre, for the maintenance treatment of chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone, as it is the first inhaled product with a novel mechanism of action for COPD maintenance to be approved in over two decades.

Ohtuvayre, known scientifically as ensifentrine, is a pioneering treatment that acts as a selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4. This dual inhibition results in bronchodilator and non-steroidal anti-inflammatory effects within a single molecule. The treatment regimen for Ohtuvayre involves twice-daily administration directly to the lungs using a standard jet nebulizer.

COPD remains an incurable condition, and despite existing maintenance therapies, most patients continue to experience daily symptoms such as breathlessness and persistent coughing. Ohtuvayre presents a new therapeutic option for the millions of individuals managing chronic COPD, given its unique capability to inhibit two critical enzymes associated with airway muscle contraction and inflammation.

The FDA's approval was underpinned by data from the phase 3 ENHANCE trials, which demonstrated that Ohtuvayre provided clinical benefits both as a standalone treatment and when used alongside other maintenance therapies.

This regulatory milestone has financial implications as well: it triggered a $5.8 million milestone payment to Ligand Pharmaceuticals, with an additional $13.8 million to be paid upon the commercial launch of the product. Verona Pharma's acquisition of Rhinopharma in 2006 included a licensing agreement that had been established a year earlier with Ligand UK Development, which became a wholly-owned subsidiary of Ligand Pharmaceuticals in 2018.

Verona Pharma is fully prepared for the launch of Ohtuvayre and anticipates that the product will be available to patients in the third quarter of 2024 through its exclusive network of specialty pharmacies. This new treatment option is expected to provide significant benefits to those struggling with the daily challenges of chronic obstructive pulmonary disease.