DuoResp Spiromax - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
budesonide / formoterol
Post-authorisationHuman
DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled with corticosteroids and ‘long-acting beta-2 agonists’ (such as budesonide and formoterol) taken by inhalation.
DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
DuoResp Spiromax has been authorised in the EU since April 2026. It is available as an inhalation powder in a portable inhaler device.
Currently DuoResp Spiromax is authorised in asthma for maintenance use and as reliever when needed in combination with maintenance treatment. The company applied for an extension of indication so it can also be used for relieving symptoms of mild asthma when needed, with no need for maintenance treatment (reliever-only treatment).
The two active substances in DuoResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
In its use as reliever-only treatment for mild asthma, DuoResp Spiromax was expected to work in the same way as it does in its existing uses.
The company presented results from published studies and recommendations from international treatment guidelines.
The application was withdrawn after the European Medicines Agency had evaluated the information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.
The Agency noted that the evidence presented did not show sufficiently that budesonide/formoterol was effective when used for reliever-only treatment in people with mild asthma.
There was a concern that the available evidence came from patients who were not fully representative of patients with asthma. There was also a concern that patients on relief-only treatment would not get enough corticosteroid (budesonide) treatment to control their asthma. In addition, the Agency noted issues with the way studies supporting the application were carried out.
Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of DuoResp Spiromax as reliever-only treatment for mild asthma did not outweigh its risks.
In its letter notifying the Agency of the withdrawal of application, the company stated that it did not have sufficient information to address the issues raised by the Agency.
The company informed the CHMP that there were no ongoing clinical trials with DuoResp Spiromax in asthma at the time of the withdrawal.
DuoResp Spiromax continues to be authorised in authorised uses.