FDA Approves Ensifentrine for Treatment of COPD

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Article

The first-in-class selective dual PDE3 and PDE4 inhibitor from Verona Pharma is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years.

The FDA has approved ensifentrine (Ohtuvayre) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients, Verona Pharmaceuticals announced in a release.1 The medication is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years.

FDA Approves Ensifentrine for Treatment of COPD / Tada Images - stock.adobe.com

FDA Approves Ensifentrine for Treatment of COPD / Tada Images - stock.adobe.com

The approval was based on data from the phase 3 ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057) trials, in which ensifentrine demonstrated clinical benefits both as a stand-alone therapy and in combination with other maintenance therapies. The treatment was seen to be well-tolerated in adult populations with moderate to severe COPD. Data from the studies was published in the American Journal of Respiratory and Critical Care Medicine.2

Key Takeaways

  • Ensifentrine (Ohtuvayre) is the first inhaled product with a novel mechanism of action approved to treat COPD in over 20 years. It is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), combining bronchodilator and non-steroidal anti-inflammatory effects in a single molecule.
  • The approval was based on data from the phase 3 ENHANCE-1 and ENHANCE-2 trials. Ensifentrine demonstrated clinical benefits both as a stand-alone therapy and in combination with other maintenance therapies.
  • Ensifentrine's approval is considered a significant advance in COPD care and offers a unique approach to treatment. The launch of Ohtuvayre is planned for the third quarter of 2024.

“COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over 2 decades,” Michael Wells, MD, associate professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, said in a release.1 “Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”

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Ensifentrine is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4). The therapy, which combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule, uses a standard jet nebulizer to deliver the medication directly to the lungs. This makes the medication easier to use because there is no need for high inspiratory flow rates or complex hand-breath coordination.

ENHANCE-1 was a randomized, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of ensifentrine over a 24 week period with a 48 week safety subset in 760 adult patients with moderate to severe COPD. ENHANCE-2 was a randomized, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of ensifentrine over 24 weeks in 790 adult patients.

During both trials, ensifentrine significantly improved average forced expiratory volume in 1 second area under the curve at 0 to 12 hours compared to placebo. The treatment also reduced the rate of moderate to severe exacerbations and increased the time to first exacerbation over the study period. Although ensifentrine was seen to significantly improve symptoms and quality of life in ENHANCE-1, those results were not seen in ENHANCE-2.

Ensifentrine was well tolerated by patients in both trials. In ENHANCE-1, 38.4% of patients who received treatment reported treatment-related adverse events, compared to 36.4% in the placebo group. In ENHANCE-2, 35.3% of patients who received treatment reported treatment-related adverse events, compared to 35.4% in the placebo group. The most common reported adverse events were nasopharyngitis, hypertension, and back pain.

COPD is a group of progressive lung disease that includes emphysema and chronic bronchitis. It is a leading cause of death in the United States and its prevalence has increased significantly in patients aged 75 years or older in the last decade. The disease also has an elevated prevalence in women and people who have ever smoked.3

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” David Zaccardelli, PharmD, president and CEO of Verona Pharma, said in a release.1 “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

READ MORE: Respiratory Resource Center

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References
1. Verona Pharma Announces US FDA Approval of Ohtuvayre™ (ensifentrine). News Release. Verona Pharma. June 26, 2024. Accessed June 27, 2024. https://www.veronapharma.com/news/verona-pharma-announces-us-fda-approval-of-ohtuvayre-ensifentrine/
2. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a Novel Phosphodiesterase 3 and 4 Inhibitor for the Treatment of Chronic Obstructive Pulmonary Disease: Randomized, Double-Blind, Placebo-controlled, Multicenter Phase III Trials (the ENHANCE Trials). Am J Respir Crit Care Med. 2023 Aug 15;208(4):406-416. doi: 10.1164/rccm.202306-0944OC. PMID: 37364283; PMCID: PMC10449067.
3. Liu Y, Carlson SA, Watson KB, et al. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ≥18 Years — United States, 2011–2021. MMWR Morb Mortal Wkly Rep 2023;72:1250–1256. DOI: http://dx.doi.org/10.15585/mmwr.mm7246a1.
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