What patients should know about ensifentrine, the newest medication for COPD

Last updated: 18 December 2024

What patients should know about ensifentrine, the newest medication for COPD

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After getting its first global approval, Ohtuvayre (ensifentrine) has become a topic of interest for all patients with chronic obstructive pulmonary disease. Due to its novel mechanism of action, the medicine offers a non-steroidal approach to managing COPD. This provides hope to patients who haven't responded well to existing treatments.

And while we wait for ensifentrine to become available around the world, what should patients know about this new medicine for COPD?

What are ensifentrine's indications?

Ensifentrine (sold under the brand name Ohtuvayre) is a prescription medicine for adults with chronic obstructive pulmonary disease (COPD) 1. At the moment this is its only approved indication. However, ensifentrine is also being studied as a potential therapy for other conditions. Including asthma, cystic fibrosis, and bronchiectasis.

Ensifentrine for asthma

Ensifentrine is being actively explored as a treatment for asthma due to its unique mechanism of action as a dual PDE3 and PDE4 inhibitor.

Asthma often involves both bronchoconstriction (narrowing of airways) and inflammation, making ensifentrine's combined action particularly promising. Most existing treatments target either airway relaxation or inflammation, but ensifentrine does both simultaneously.

While Ohtuvayre is not yet approved for treating asthma, previous clinical trial data points to its potential as a treatment for the condition. In a series of trials among asthma patients, ensifentrine was shown to:

  • Increase bronchodilation by 14% compared to placebo;
  • Increase FEV1 compared to placebo over 6 hours on days 1,3, and 6 3.

Further trials will show if and when Ohtuvayre could be approved for use in asthma.

Ensifentrine for cystic fibrosis

While ensifentrine is not primarily developed for treating cystic fibrosis (CF), its mechanism of action aligns with the respiratory symptoms of CF. Patients with CF often suffer from airway obstruction due to mucus build-up and inflammation. Any therapy reducing inflammation and improving airflow could theoretically offer benefits.

As such, ensifentrine could be a candidate for further research. However, as of December 2024, there are no ongoing clinical trials focusing specifically on ensifentrine in cystic fibrosis.

Ensifentrine and bronchiectasis

Ensifentrine has potential relevance for bronchiectasis due to its dual mechanism of bronchodilation and anti-inflammatory effects. They address the primary issues in bronchiectasis: airway obstruction and chronic inflammation.

Ohtuvayre's dual mechanism could have a potential advantage over current bronchiectasis therapies, as they often focus solely on treating mucus buildup or inflammation, but not both.

Currently, a Phase 2 clinical trial is underway to further explore ensifentrine's safety and efficacy in treating non-cystic fibrosis bronchiectasis 2. Results are expected in 2026.

How does ensifentrine work?

Ensifentrine functions as a dual inhibitor of the PDE3 and PDE4 enzymes. Thus, it delivers both bronchodilation and anti-inflammatory benefits. It relaxes the smooth muscles in the airways and diminishes inflammatory responses. Unlike conventional COPD therapies that focus solely on either bronchodilation or inflammation, ensifentrine integrates both effects into a single, non-steroidal treatment option.

Is ensifentrine a first line medication for COPD?

According to its prescribing information, ensifentrine is intended as maintenance therapy for COPD. However, it can also serve as a first-line medication for the condition, according to Prof. Antonio Anzueto of South Texas Veterans Healthcare System 4.

Therefore, at your treating doctor's discretion and depending on your personal situation, you may be prescribed Octuvayre as a first-line therapy for your COPD.

What patients should know about taking Ohtuvayre

Unlike some other COPD medicines, ensifentrine can be used by patients themselves. A health professional is not needed to administer the medicine. Ensifentrine is inhaled via a nebulizer - a fairly straightforward process that takes 5-7 minutes 4.

Can ensifentrine be mixed with other meds in a nebulizer?

No. Ensifentrine should not be mixed with other medicines in your nebulizer.

Note that this doesn't mean you cannot combine ensifentrine with other COPD medicines you may be taking. To the contrary, Ohtuvayre can be used as an add-on to your current therapy. However, you should take each of your current medicines as prescribed and not mix them together 5.

How does ensifentrine compare to other COPD medicines?

What makes ensifentrine a novel medicine, and what are the differences between it and other standard COPD treatments?

Ensifentrine vs roflumilast

Daliresp (roflumilast) is a commonly prescribed COPD medicine. Here are some of the ares in which it differs from Ohtuvayre (ensifentrine):

  • Mechanism of action: Roflumilast is a selective PDE4 inhibitor that reduces inflammation, but does not provide bronchodilation. In contrast, ensifentrine inhibits both PDE3 and PDE4, improving airflow and reducing inflammation;
  • Administration: Roflumilast is taken as a tablet, which takes longer to act and may have more systemic side effects compared to ensifentrine, which is inhaled via a nebulizer and acts directly in the lungs.

Ohtuvayre vs Dupixent (dupilumab)

Dupixent can sometimes be used with COPD inhalers to reduce the number of flare-ups and help improve lung function. Here's how it differs from ensifentrine:

  • Mechanism of action: While ensifentrine inhibits the PDE3 and PDE4 enzymes, dupixent inhibits IL-4 and IL-13, which play a role in allergic and inflammatory responses;
  • Administration: While ensifentrine is an inhaled medicine, Dupixent is administered as an injection. As such, it cannot be used to relieve sudden breathing problems or replace an inhaled COPD medicine.

When will Ohtuvayre be available for patients?

That really depends on your location. If you're in the USA, Ohtuvayre is probably already available to you, based on Verona Pharma's plan to launch in the third quarter of 2024 6.

However, if you're based elsewhere, timelines for availability are less clear. Ohtuvayre is awaiting EMA approval, which may take up to a year from the moment an application is submitted (which is currently not the case).

There are no timeline indications for ensifentrine's approval in Canada, Australia, India, or elsewhere. It's likely going to take some time until Ohtuvayre is available to all COPD patients.

Fast access to Ohtuvayre

While medicine approval processes take time, the good news is you don't have to wait. If your treating doctor prescribes ensifentrine to you, you can buy and import it for your personal use, before the medicine is available in your country.

If you have a prescription for Ohtuvayre and are eager to start your treatment with the newest COPD medicine, get in touch with our expert team. We'll help you get the medicine immediately. Wherever you are.