Rolufta Ellipta (previously Rolufta)
Authorised
This medicine is authorised for use in the European Union
umeclidinium
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Rolufta Ellipta is used for maintenance (regular) treatment.
Rolufta Ellipta contains the active substance umeclidinium bromide.
Rolufta Ellipta is available as an inhalation powder in a portable inhaler device. Each inhalation provides 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium. The recommended dose is one inhalation per day at the same time each day. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet or contact your doctor or pharmacist.
The medicine can only be obtained with a prescription.
The active substance in Rolufta Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist. It works by blocking the action of so-called muscarinic receptors, which control the contraction of muscles. When umeclidinium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.
Rolufta Ellipta was investigated in four main studies involving over 4,000 patients. Three studies compared Rolufta Ellipta with placebo (a dummy treatment), while one study compared Rolufta Ellipta with tiotropium (another medicine for COPD). The main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Results showed that Rolufta Ellipta improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment. A double dose of Rolufta Ellipta only showed small improvements compared with a single dose, which were not considered relevant. In the study comparing Rolufta Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
The studies also showed an improvement in symptoms such as breathlessness and wheezing.
The most common side effects with Rolufta Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
For the full list of side effects and restrictions with Rolufta Ellipta, see the package leaflet.
The European Medicines Agency decided that Rolufta Ellipta’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that Rolufta Ellipta was shown to be effective at improving the lung function and symptoms of COPD. The Agency also noted that there were no major safety concerns with Rolufta Ellipta, with side effects being manageable and similar to other medicines of the same class (antimuscarinic bronchodilators).
As medicines of the same class as Rolufta Ellipta may have an effect on the heart and blood vessels, the company that markets Rolufta Ellipta will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rolufta Ellipta have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rolufta Ellipta are continuously monitored. Side effects reported with Rolufta Ellipta are carefully evaluated and any necessary action taken to protect patients.
Rolufta Ellipta received a marketing authorisation valid throughout the EU on 20 March 2017. This authorisation was based on the authorisation granted to Incruse Ellipta in 2014 (‘informed consent’).
Product information
Latest procedure affecting product information:
WS2816
14/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Rolufta Ellipta (previously Rolufta)
- Active substance
- umeclidinium bromide
- International non-proprietary name (INN) or common name
- umeclidinium
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03BB07
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
News on Rolufta Ellipta (previously Rolufta)
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