Ohtuvayre
Application withdrawn
The application for this medicine has been withdrawn
ensifentrine
Medicine
Human
Application withdrawn
- Application under evaluation
- Withdrawal of application
Overview
Verona Pharma Ireland Limited withdrew its application for a marketing authorisation of Ohtuvayre for the treatment of chronic obstructive pulmonary disease (COPD).
The company withdrew the application on 30 October 2025.
Ohtuvayre was developed as a medicine for maintenance treatment for adults with symptoms of chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.
Ohtuvayre contains the active substance ensifentrine and was to be inhaled using a standard jet nebuliser.
The active substance in Ohtuvayre, ensifentrine, blocks the actions of two enzymes (proteins) called phosphodiesterase type 3 and phosphodiesterase type 4. Type 3 is involved in contraction of the muscles in the airways of the lungs, while type 4 is involved in inflammation.
By blocking the actions of these enzymes, the medicine was expected to widen the airways and reduce inflammation in the lungs, making it easier to breathe.
The company presented results from two main studies involving 1,553 people with moderate-to-severe COPD. The studies compared Ohtuvayre with placebo (a dummy treatment) and looked at the change in a measure of FEV₁ after 12 weeks of treatment. FEV₁, or forced expiratory volume in 1 second, is the most air a person can breathe out in 1 second.
The application was withdrawn while the European Medicines Agency was still evaluating the initial information from the company.
As the Agency was still evaluating the initial information from the company, it had not yet made any recommendations.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application following a review of its priorities.
The company informed the Agency that the withdrawal will have no consequences for people in clinical trials using Ohtuvayre.
If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Key facts
- Name of medicine
- Ohtuvayre
- Active substance
- ensifentrine
- International non-proprietary name (INN) or common name
- ensifentrine
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03BX
- EMA product number
- EMEA/H/C/006742
- Marketing authorisation applicant
- Verona Pharma Ireland Limited
- Withdrawal of application
- 30/10/2025
All documents
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