"Nuance Pharma has received approval from the Pharmaceutical Administration Bureau of Macau for Ohtuvayre™ (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults.
Ohtuvayre™ is the first inhaled therapy for COPD maintenance that combines bronchodilator and non-steroidal anti-inflammatory properties in one molecule.
The treatment was assessed in Verona Pharma’s Phase 3 ENHANCE trials, which confirmed statistically significant and clinically meaningful improvements in lung function in COPD patients receiving the therapy.
Ohtuvayre™ was first approved in the United States in June 2024 and became available commercially in August. It is a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4), combining bronchodilator and non-steroidal anti-inflammatory effects in a single molecule.
The treatment is delivered via a standard jet nebuliser, without requiring high inspiratory flow rates or complex hand-breath coordination.
The regulatory approval in Macau SAR, China, is based on extensive clinical data, including findings from the global Phase 3 ENHANCE trials.
These trials, published in the American Journal of Respiratory and Critical Care Medicine, demonstrated the efficacy of Ohtuvayre™ both as a standalone therapy and in combination with other maintenance treatments.
The results also indicated that the drug was well tolerated in patients with moderate to severe COPD.
The approval in Macau SAR marks the first regulatory clearance for Ohtuvayre™ outside the United States.
Nuance Pharma is expanding access to the treatment in China through early access programmes in Hainan BoAo and the Greater Bay Area (GBA), ahead of an expected new drug application (NDA) submission in 2025 following the completion of the ENHANCE-CHINA trial.
Ohtuvayre™ was launched in November 2024 in China’s Hainan Boao Pilot Zone under an early access programme. Recruitment for the ENHANCE-CHINA Phase 3 clinical trial was completed in September 2024.
Nuance Pharma holds exclusive rights to develop and commercialise Ohtuvayre™ in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, under a licensing agreement established in 2021 with Verona Pharma.