FDA Approves Ensifentrine for Maintenance Treatment of Chronic Obtrusive Pulmonary Disorder

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After over 2 decades, the first inhaled product with a novel mechanism of action has been approved by the FDA for the treatment of chronic obtrusive pulmonary disorder.

The FDA has approved ensifentrine (Ohtuvayre; Verona Pharma) for the maintenance treatment of chronic obtrusive pulmonary disease (COPD) in adult patients, according to a press release from Verona Pharma.1

Word COPD is made of wooden cubes with stethoscope and medicine mask. | Image credit: Maks_Lab - stock.adobe.com

Image credit: Maks_Lab - stock.adobe.com

According to Verona, this is the first inhaled product with a novel mechanism of action that is available for maintenance treatment of COPD in over 20 years.1

Ensifentrine is a selective dual inhibitor of the phosphodiesterase 3 and phosphodiesterase 4 enzymes, which combines bronchodilator and non-steroidal anti-inflammatory effects into 1 molecule. Through a standard jet nebulizer, ensifentrine Is delivered directly to the lungs, without any high inspiratory flow rates or complicated hand-breath coordination necessary.1

“The approval of [ensifentrine] is a significant advance in COPD care, and we believe [ensifentrine's] novel profile can change the treatment paradigm for COPD,” David Zaccardelli, PharmD, president and chief executive officer of Verona Pharma, said in the news release. He said that the company plans to launch ensifentrine in the third quarter of 2024 through an exclusive network of accredited specialty pharmacies.1

This approval is based off a wealth of evidence from previously conducted trials, including the ENHANCE phase 3 trials, which found that ensifentrine treatment significantly improved both COPD symptoms and quality of life in patients.2

In these trials,–ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057)–there were 760 and 789 patients randomized and treated, respectively. Forced expiratory volume (FEV1) percentage was measured among the patients to determine the effectiveness of ensifentrine.2

The investigators found that ensifentrine treatment significantly improved average FEV1 area under the curve at 0 to 12 hours when compared to the placebo (ENHANCE-1, 87 ml [95% CI: 55, 119]; ENHANCE-2, 94 ml [65, 124]; both P < 0.001).2

Critically, ensifentrine reduced the rate of moderate or severe exacerbations in these patients over 24 weeks compared to the placebo (ENHANCE-1, rate ratio, 0.64 [0.40, 1.00]; P = 0.050; ENHANCE-2, rate ratio, 0.57 [0.38, 0.87]; P = 0.009).2

In addition, there was an increased time to first exacerbation when using ensifentrine (ENHANCE-1, hazard ratio, 0.62 [0.39, 0.97]; P = 0.038; ENHANCE-2, hazard ratio, 0.58 [0.38, 0.87]; P = 0.009).2 The drug induced these clinical benefits when used both alone and with other maintenance therapies, as well as being well-tolerated among a broad population of subjects that had moderate to severe COPD.2

In each trial, there was a lack of adverse effects due to ensifentrine; additionally, the drug was well tolerated and not associated in either increased gastrointestinal issues or an increase in pneumonia.2

“In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the [United States], and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over 2 decades,” Michael Wells, MD, an associate professor in the division of pulmonary, allergy, and critical care medicine at the University of Alabama Birmingham, said.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,” he continued.1

The study authors of the ENHANCE trials concluded by saying, “These results indicate that ensifentrine, with a novel PDE3 and PDE4 inhibition mechanism, would be a valuable and complementary addition to the limited available treatment mechanisms for patients with COPD.”2

References
1. Verona Pharma. Verona Pharma announces US FDA approval of Ohtuvayre™ (ensifentrine). Press release. Published 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 I, Siler T, 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). AJRCCM. 2023;208(4). doi:10.1164/rccm.20236-0944OC
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