Verona Gets Ohtuvayre Approval for COPD

FDA has approved a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is described as the “first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.” Approval was based on data from the Phase 3 ENHANCE trials (see American Journal of Respiratory and Critical Care Medicine) which demonstrated clinical benefits both alone and when used with other maintenance therapies, Verona says.

The first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (PDE3 and PDE4) combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, according to Verona. It is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination, it says.