Ohtuvayre FDA Approval History
Last updated by Judith Stewart, BPharm on July 1, 2024.
FDA Approved: Yes (First approved June 26, 2024)
Brand name: Ohtuvayre
Generic name: ensifentrine
Dosage form: Inhalation Suspension
Company: Verona Pharma plc
Treatment for: COPD, Maintenance
Ohtuvayre (ensifentrine) is a selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
- COPD refers to a group of diseases that cause airflow blockage and breathing-related problems. It includes emphysema and chronic bronchitis.
- Ohtuvayre works in the treatment of COPD through combined bronchodilator and non-steroidal anti-inflammatory actions.
- FDA approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) trials, in which Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function.
- Ohtuvayre inhalation suspension is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.
- Warnings and precautions associated with Ohtuvayre include paradoxical bronchospasm, and an increase in psychiatric adverse reactions, including suicidality.
- Common adverse reactions (incidence greater and equal to 1% and more common than placebo) include back pain, hypertension, urinary tract infection, and diarrhea.
Development timeline for Ohtuvayre
Further information
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