Nuance Pharma announced today that the Pharmaceutical Administration Bureau of Macau has approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. This approval marks the first regulatory clearance for the innovative therapy outside the United States, where it received approval in June 2024 and became commercially available in August.
Ohtuvayre represents a significant advancement in COPD treatment as the first inhaled therapy that combines bronchodilator and non-steroidal anti-inflammatory activities in a single molecule. The drug works as a selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3; PDE4), delivering its therapeutic effects directly to the lungs through a standard jet nebulizer without requiring high inspiratory flow rates or complex hand-breath coordination.
Novel Dual-Action Mechanism Addresses Key COPD Pathways
The approval in Macau was supported by comprehensive data from the global Phase 3 ENHANCE clinical trials, published in the American Journal of Respiratory and Critical Care Medicine. These studies demonstrated that Ohtuvayre provides clinical benefits both as monotherapy and when used alongside other maintenance treatments. The drug showed statistically significant and clinically meaningful improvements in lung function while maintaining a favorable safety profile in a broad population of patients with moderate to severe COPD.
Mark Lotter, founder and Chief Executive Officer of Nuance Pharma, highlighted the significance of this regulatory milestone: "We are pleased to announce that the Macau regulatory authority has approved the NDA of Ohtuvayre, which also marks the first regulatory approval outside of the US. We are proud to provide access to this highly innovative COPD treatment to patients in Macau and beyond, for example through innovative policy in the Greater Bay Area (GBA)."
Expanding Access Across Greater China
Nuance Pharma has already initiated early access programs for Ohtuvayre in strategic locations within China. In November 2024, the company launched the therapy in China's Hainan Boao Pilot Zone through an early access program. This follows the September 2024 completion of recruitment for ENHANCE-CHINA, the Phase 3 clinical trial of ensifentrine specifically designed to support regulatory approval for COPD maintenance treatment in mainland China.
"Respiratory disease is among Nuance's core areas of focus, and through approval in Macao SAR and early access programs in Hainan BoAo and GBA, Nuance Pharma is looking forward to providing this novel, first-in-class treatment to patients in China, prior to our expected NDA submission in 2025 upon completion of the ENHANCE-CHINA trial," Lotter added.
David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, the developer of ensifentrine, expressed optimism about the therapy's potential impact: "We are very pleased that Ohtuvayre is available to help patients still experiencing daily COPD symptoms. We are encouraged by the initial impact of Ohtuvayre and believe its novel profile can re-define the COPD treatment paradigm."
Strategic Partnership Drives Regional Development
The development and commercialization of Ohtuvayre in the region stems from a 2021 agreement between Nuance Pharma and Verona Pharma, granting Nuance exclusive rights to develop and commercialize the therapy throughout Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
COPD represents a significant health burden globally and in China specifically. The progressive respiratory condition is characterized by persistent airflow limitation, chronic inflammation, and recurring exacerbations that significantly impact patients' quality of life. Current treatment options often address either the bronchospasm or inflammatory components of the disease separately, making Ohtuvayre's dual mechanism particularly valuable for comprehensive symptom management.
The therapy's approval in Macau provides an important new option for COPD patients in the region and signals potential broader availability throughout Greater China following the anticipated regulatory submission in mainland China next year.
