The U.S. FDA has approved Verona Pharma's inhaled nonsteroidal nebulizer therapy for the maintenance treatment of chronic obstructive pulmonary disease (COPD), marking the first inhaled product with a novel mechanism of action available for COPD maintenance in more than 20 years.
Ensifentrine, branded Ohtuvayre, is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The twice-daily treatment is delivered directly to the lungs through a standard jet nebulizer.
There is no cure for COPD and, according to Verona, even with maintenance therapy, most patients deal with daily symptoms such as breathlessness and persistent coughing. Ohtuvayre, with its ability to inhibit two key enzymes involved in airway muscle contraction and inflammation, brings a new treatment option to the millions of people managing chronic COPD.
The approval was based on data from the phase 3 ENHANCE trials, where Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies.
The FDA nod triggered a $5.8 million milestone payout to Ligand Pharmaceuticals, as well as an additional $13.8 million upon commercial launch. In 2006, Verona acquired Rhinopharma and with that buy came a licensing deal the company had signed a year prior with Ligand UK Development (which became a wholly owned subsidiary of Ligand Pharmaceuticals in 2018).
Verona says it is fully staffed to launch and expects Ohtuvayre to be available in the third quarter 2024 through its exclusive network of specialty pharmacies.
