New COPD Drug Is a True Multitasker

Key Takeaways

• The FDA approved Ohtuvayre (ensifentrine) as a maintenance therapy for COPD (chronic obstructive pulmonary disease).
• The medication works as both a bronchodilator and an anti-inflammatory to ease breathing while also helping clear mucus from the lungs.
• Ensifentrine reduced severe exacerbations by as much as 43 percent in clinical trials.

People with the lung disease COPD (chronic obstructive pulmonary disease) have a new treatment option: a multitasking medication called Ohtuvayre (ensifentrine) that was just approved by the U.S. Food and Drug Administration (FDA) as a maintenance therapy.

COPD involves persistent inflammation in the airways that blocks airflow from the lungs and causes breathing problems and symptoms like coughing, wheezing, and shortness of breath. For decades, standard COPD medications have included options such as inhaled bronchodilators to relax muscles around the airways, steroids to reduce airway inflammation, and anticholinergics to encourage clearing of mucus from the lungs.

Ensifentrine is a new type of COPD drug that's designed to do several things at once: It serves as a bronchodilator, an anti-inflammatory, and a mucus-removal aid. Ensifentrine accomplishes this by acting on two enzymes in the lungs - phosphodiesterase 3 and phosphodiesterase 4 - that play a role in managing airway inflammation and muscle movements in the lungs.

The medication is delivered directly to the lungs through a standard jet nebulizer.

"We believe its bronchodilator and nonsteroidal anti-inflammatory activity has the potential to change the treatment paradigm," said David Zaccardelli, PharmD, the president and chief executive of ensifentrine's developer, Verona Pharma, in a statement. The drug, he added, is "the first novel mechanism available for the maintenance treatment of COPD in more than 10 years."

How Does Ensifentrine Work?

In two clinical trials reviewed by the FDA prior to drug approval, researchers randomly assigned about 1,500 adults with moderate to severe COPD symptoms to take either ensifentrine or a placebo twice daily for 24 weeks.

Compared with the placebo, ensifentrine significantly improved what's known as forced expiratory volume (FEV1), or how much air somebody can exhale during a one-second breath. People taking ensifentrine were also 36 to 43 percent less likely to experience severe COPD exacerbations, according to results of the two trials published in the American Journal of Respiratory and Critical Care Medicine .

Slightly more than one-third of patients taking ensifentrine experienced side effects related to treatment, similar to the proportion in the placebo group, the trials found. Roughly 6 to 10 percent of people on both ensifentrine and placebo stopped treatment due to side effects. Some common side effects included colds, elevated blood pressure, and back pain.

Another COPD Drug Approval Is on the Horizon

As another potential new option for COPD, the FDA is currently reviewing data and considering whether to okay Dupixent (dupilumab) , a drug the agency has already approved for conditions including asthma and atopic dermatitis (commonly referred to as eczema). A decision is expected in September, according to a statement from the drug's developers, Sanofi and Regeneron.

In clinical trials, dupilumab reduced the annual odds of moderate to severe acute COPD exacerbations by up to 34 percent, according to the statement.

Pulmonologists Are Excited to Have More Treatment Options

Both dupilumab and ensifentrine represent promising new therapies for COPD that appear to be both safe and highly effective, says Antonio Anzueto, MD , a professor and specialist in pulmonology and critical care medicine at the University of Texas Health Science Center at San Antonio.

"I am very excited about these medications," Dr. Anzueto says. "Both will provide important additional treatment options to our patients."

Editorial Sources and Fact-Checking

Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy . We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.

Sources

1. Verona Pharma Announces U.S. FDA Approval of Ohtuvayre™ (Ensifentrine). Verona Pharma . June 26, 2024.
2. Verona Pharma Announces the U.S. FDA Has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD. Verona Pharma . September 11, 2023.
3. Anzueto A 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). American Journal of Respiratory and Critical Care Medicine . August 15, 2023.
4. Update on FDA Priority Review of Dupixent for the Treatment of COPD Patients With Type 2 Inflammation. Sanofi . May 31, 2024.