Winrevair
Authorised
This medicine is authorised for use in the European Union
Sotatercept
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Winrevair is a medicine used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH). Patients with PAH have an abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.
Winrevair is used in combination with other PAH medicines in patients with moderate or marked limitations of physical activity (corresponding to WHO functional class II or III respectively).
PAH is rare, and Winrevair was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2020. Further information on the orphan designation can be found on the EMA website.
Winrevair contains the active substance sotatercept.
Treatment with Winrevair should be started and supervised by a doctor experienced in the diagnosis and treatment of PAH. The medicine can only be obtained with a prescription.
Winrevair is available as a powder to be mixed with water to make a solution. It is given by injection with a syringe under the skin of the abdomen (belly), upper arm or upper thigh, every 3 weeks. Patients or their caregiver may inject Winrevair themselves after they have been trained to do so.
Before each of the first 5 doses of Winrevair, the doctor will verify that the patient’s platelet levels are high enough and haemoglobin levels are not too high. These tests will then be carried out every 3 to 6 months. The doctor may adjust the dose, interrupt or stop treatment if certain side effects occur.
For more information about using Winrevair, see the package leaflet or contact your doctor or pharmacist.
The active substance in Winrevair, sotatercept, attaches to and blocks a protein called activin. By doing so, it prevents the thickening and narrowing of small blood vessels in the lungs, thereby lowering blood pressure and making it easier for the heart to pump blood.
A main study has shown that Winrevair was more effective than placebo (a dummy treatment) at improving the ability of adults with PAH to exercise. The main measure of effectiveness was the difference in the distance patients could walk in 6 minutes before and after treatment.
In this study, involving 323 patients with PAH, after 24 weeks of treatment, Winrevair given in addition to other PAH medicines improved the distance patients could walk in 6 minutes by around 34 meters, compared with 1 meter in patients who had placebo in place of Winrevair.
For the full list of side effects and restrictions with Winrevair, see the package leaflet.
The most common side effects with Winrevair (which may affect more than 1 in 10 people) include headache, epistaxis (nosebleed), telangiectasia (small red blood vessels in the skin), diarrhoea, dizziness, rash and thrombocytopenia (low levels of blood platelets).
The most common serious side effects with Winrevair (which may affect up to 1 in 100 people) include thrombocytopenia and epistaxis.
Winrevair must not be given to patients whose platelet levels are consistently low (less than 50 x 109/L) as it may increase the risk of bleeding. Winrevair should also not be used during pregnancy as it may harm the foetus.
In a main study, Winrevair was shown to improve the ability of patients with PAH to exercise. Regarding safety, the side effects of Winrevair were considered manageable. There are limited data about the cardiovascular (affecting the heart or blood circulation) safety of Winrevair and more data are required.
The European Medicines Agency therefore decided that Winrevair’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Winrevair must provide the results of a study assessing the cardiovascular safety of Winrevair.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Winrevair have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Winrevair are continuously monitored. Suspected side effects reported with Winrevair are carefully evaluated and any necessary action taken to protect patients.
Winrevair received a marketing authorisation valid throughout the EU on 22 August 2024.
Product information
Latest procedure affecting product information:
VR/0000246288
28/03/2025
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
- Winrevair
- Active substance
- sotatercept
- International non-proprietary name (INN) or common name
- Sotatercept
- Therapeutic area (MeSH)
- Hypertension, Pulmonary
- Anatomical therapeutic chemical (ATC) code
- C02KX06
Pharmacotherapeutic group
AntihypertensivesTherapeutic indication
Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity (see section 5.1).
News on Winrevair
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