Ensifentrine

In 2024, the FDA approved dupilumab (Dupixent) as the first biologic for COPD, offering new treatment options. Dupilumab, approved for adults with uncontrolled COPD and an eosinophilic phenotype, demonstrated significant reductions in COPD exacerbations and improvements in lung function in phase 3 trials BOREAS and NOTUS.

In 2025, pulmonology advances include new COPD treatments like ensifentrine (Ohtuvayre) and dupilumab (Dupixent), the first biologic therapy for COPD. Ensifentrine, a dual inhibitor of phosphodiesterase 3 and 4, improved FEV1 and reduced exacerbations in trials. Dupilumab, approved for COPD with eosinophilic phenotype, reduced exacerbations and improved lung function in BOREAS and NOTUS trials.

Verona Pharma announced FDA approval of Ohtuvayre (ensifentrine) for COPD maintenance treatment in adults, marking the first novel inhaled product in over 20 years. Ohtuvayre, a dual PDE3/PDE4 inhibitor, combines bronchodilator and anti-inflammatory effects. Wilson Sonsini Goodrich & Rosati advised on patent matters.

Ensifentrine, a dual PDE3/PDE4 inhibitor, showed significant improvements in lung function and quality of life in COPD patients of varying severity, according to a post-hoc analysis of the ENHANCE phase 3 trials. Presented at CHEST 2024, the findings highlight ensifentrine's efficacy in both moderate and severe COPD subgroups, with improvements in FEV1 AUC(0-12h), peak FEV1, and QoL measures.

COPD treatment advances include precision medicine, biologics like dupilumab, biomarkers for early diagnosis, remote monitoring, omics tech, and regenerative medicine, promising more personalized and effective care.

Verona Pharma presents Phase 3 ENHANCE studies on Ohtuvayre (ensifentrine), a first-in-class dual PDE3/PDE4 inhibitor for COPD, at CHEST 2024, showing efficacy in lung function, symptoms, and quality of life across various patient subgroups.

Nuance Pharma completes patient recruitment for ENHANCE-CHINA phase 3 trial of ensifentrine (Ohtuvayre™) for COPD treatment in China, following US FDA approval in 2024. The trial, led by Professor Zhong Nanshan, aims to evaluate efficacy and safety over 24 weeks in 46 hospitals.

Verona Pharma's Ensifentrine (Ohtuvayre) received FDA approval for COPD in June, leading to a stock surge. The company plans to launch Ensifentrine this quarter at $2,950/month, targeting additional respiratory diseases. Analysts maintain Buy ratings with price targets of $34-$37/share. Verona ended H1 2024 with $400M in cash, aiming to fund operations beyond 2026. The stock is up 90% since approval, but the company is years from profitability. The focus is on high-volume prescribers and Medicare/insurance approvals.