FDA Greenlights Ohtuvayre?: A New Era in COPD Treatment
SciFocus/Aug 15, 2024 -- Verona Pharma has secured FDA approval for Ohtuvayre? (ensifentrine), a groundbreaking treatment for chronic obstructive pulmonary disease (COPD). This marks the first inhaled COPD therapy with a novel mechanism of action to be approved in over two decades, offering hope to millions of patients who struggle with daily symptoms.
Highlights:
- FDA Approval: Ohtuvayre? (ensifentrine) receives FDA approval for maintenance treatment of COPD in adult patients.
- Innovative Mechanism: First-in-class dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), combining bronchodilation and non-steroidal anti-inflammatory effects.
- Administration: Delivered via a standard jet nebulizer, Ohtuvayre? is user-friendly, requiring no complex hand-breath coordination.
- Clinical Impact: Demonstrated efficacy in Phase 3 ENHANCE trials, showing benefits both as a standalone treatment and in combination with other maintenance therapies.
- Availability: Expected to launch in Q3 2024, with distribution through a network of accredited specialty pharmacies.
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