Ensifentrine's EMA approval: When will the newest inhaled COPD medicine be available in Europe?

After over 20 years without a novel treatment for chronic obstructive pulmonary disease (COPD), the FDA's approval of Ohtuvayre (ensifentrine) is changing the treatment landscape.

And while this is positive news, it means little to patients outside the USA, where Ohtuvayre is not yet available. When can patients specifically in Europe and the UK expect ensifentrine to be approved?

What is ensifentrine used for?

The newest inhaled medicine for COPD is used as a maintenance treatment for patients. It combines bronchodilator and anti-inflammatory activities in one molecule. As a first-in-class dual PDE3 and PDE4 inhibitor, ensifentrine offers a unique approach to disease management.

Ohtuvayre can be used alone or with other COPD treatments.

Is ensifentrine a steroid?

No, ensifentrine is not a steroid. The novelty of the medicine is that it has a different mechanism of action compared to COPD treatments used to date. It works by decreasing the activity of the PDE3 and PDE4 enzymes, thus improving lung function and alleviating symptoms ¹.

How effective is ensifentrine in clinical trials?

Ohtuvayre (ensifentrine) has completed two Phase 3 trials - ENHANCE-1 and ENHANCE-2. In both trials, ensifentrine was compared against placebo in the effect it had on forced expiratory volume (FEV). FEV is a critical measurement of lung function, indicating the volume of air someone can exhale within a specific time frame. In the case of the ENHANCE clinical trials, this timeframe was one second.

The key reported results from the two trials were:

ENHANCE-1 trial results

• After 12 weeks of treatment, the FEV of patients taking Ohtuvayre increased by 61 mL on average. For patients in the placebo group, FEV decreased by 26 mL on average ².
• Patients taking Ohtuvayre reported a statistically significant improvement in their SGRQ score. SGRQ is a self-reported questionnaire that measures the health status and quality of life in patients with COPD ².

ENHANCE-2 trial results

• After 12 weeks of treatment, the FEV of patients taking Ohtuvayre increased by 48 mL on average. For patients in the placebo group, FEV decreased by 46 mL on average ².
• Patients on ensifentrine showed clinically meaningful improvements in symptoms and quality of life by week 24. However, the difference from placebo wasn’t statistically significant ³.

Based on these clinical trial results, the dual inhibitor ensifentrine got its FDA approval and set high expectations as a COPD maintenance treatment.

When will ensifentrine get EMA approval?

It's difficult to say. As of December 2024, there is no active marketing authorization application for ensifentrine in Europe. The EMA approval process typically takes up to 210 days, so if an approval application is submitted before the end of the year, ensifentrine could, at least theoretically, get EMA approval by the end of 2025.

When will Ohtuvayre be available in Europe?

EMA approval is not the same as availability, unfortunately. So, while the prospect of waiting for at least a year for Ohtuvayre to be approved in the EU isn't encouraging, the timeline for its availability across Europe is even less so.

After EMA approval, each member state goes through its own process of price negotiation, reimbursement decisions and, eventually, local launch. While some countries, like Germany, manage this process within 133 days on average, others, like Romania, can take over 800 days.

In other words, even in the best-case scenario where Ohtuvayre gets EMA approval by the end of 2025, patients around the EU would be able to access it somewhere between mid-2026 and 2028.

Will ensifentrine be available in the UK (and on the NHS)?

It's hard to say at this point. As of December 2024, there is no marketing authorization application submitted to the MHRA for Ohtuvayre. There is also no NICE assessment underway for the medicine, and a positive assessment is needed if ensifentrine is to be made available on the NHS.

While this may seem discouraging, it doesn't have to be. After Brexit, the MHRA can approve medicines as soon as another trusted agency (like the FDA or EMA) approves them. This means that if they choose to, the MHRA can immediately license Ohtuvayre in the UK, based on its FDA approval. Whether that happens, remains to be seen.

How to get ensifentrine before it's available in your country

There's good news. You don't need to wait for Ohtuvayre to become approved or available in your country in order to start your treatment. Now that the medicine has its first global approval, any patient around the world can buy and import it into their country for personal use, as long as they have a prescription.

This is made possible by the Named Patient Import regulation in effect in almost all countries around the world.

If your doctor believes that Ohtuvayre can benefit your condition, they are allowed to prescribe it already, regardless of whether it is approved or available in your country.

Already have a prescription? Share it with our team and we'll help you buy ensifentrine before its EMA approval.

References:

1. Why Ohtuvayre. Ohtuvayre.com, Accessed 10 December 2024.
2. Clinical Data & Efficacy. Ohtuvayre.com, Accessed 10 December 2024.
3. Verona Pharma Announces Ensifentrine Meets Primary Endpoint in Phase 3 ENHANCE-2 Trial for COPD. Verona Phama, Accessed 10 December 2024.