> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Verona Gets Ohtuvayre Approval for COPD
- URL: https://www.fdaweb.com/verona-gets-ohtuvayre-approval-for-copd/
- Published: 2024-06-26T12:00:00.000Z
- Updated: 2026-09-14T14:34:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157260

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*](https://www.globenewswire.com/Tracker?data=rb2b1kXhDk735nDEiymi6TugFJjMSRkQGgWsq2Ypq6a%5FMwoYJx6WJ4drOABK-Sx2MG4hPxDiR4A3RWRDr7a1BAPo3dJ4-8usGpx2PM5q4Dfg%5FrckqPi32XT6zuP8ULHsRRPlTv5vCy8Ir5NDeeWO4oo7MGppKoIHCSrKfbLM0MA2milz%5FKjhxTMTMMhTwGCIjABSnr-Ui5KUbN4Ecd9mMuxykBULmPS58eQDKFX-oWY=&ref=fdaweb.com)) 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.