Verquvo
Authorised
This medicine is authorised for use in the European Union
vericiguat
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Verquvo is a medicine used to treat adults with long-term heart failure with reduced ejection fraction who recently received intravenous (into the vein) treatment because of worsening of their symptoms. Heart failure with reduced ejection fraction is when the heart does not pump blood as well as it should, especially when the amount of blood being pumped out of the heart is less than the body needs. Some common symptoms of heart failure are shortness of breath, tiredness, or swelling caused by a build-up of fluid.
Verquvo contains the active substance vericiguat.
Verquvo is available as tablets, and the recommended starting dose is 2.5 mg once a day. The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once a day, if tolerated. The dose should be lowered or Verquvo stopped if the patient does not tolerate the medicine well. Verquvo is given in combination with other treatments for heart failure.
The medicine can only be obtained with a prescription. For more information about using Verquvo, see the package leaflet or contact your healthcare provider.
The active substance in Verquvo, vericiguat, stimulates an enzyme called ‘soluble guanylate cyclase’ (sGC) in the blood vessels, which causes them to relax and widen, making it easier for the heart to pump blood out.
Verquvo has been shown to be effective in treating heart failure in one main study involving over 5,000 patients with long-term heart failure and reduced ejection fraction who had been recently treated for an increase in their symptoms. In the study, which lasted around one year, patients were given either Verquvo or placebo (a dummy treatment) in combination with other medicines for heart failure.
In the group treated with Verquvo, 35.5% of patients (897 out of 2,526) either died as a result of heart and circulation problems or were admitted to hospital with heart failure, compared to 38.5% (972 out of 2,524) of patients given placebo.
The most common side effect with Verquvo (which may affect more than 1 in 10 people) is hypotension (low blood pressure).
Verquvo must not be used together with other sGC stimulators, such as riociguat.
For the full list of side effects and restrictions of Verquvo, see the package leaflet.
The main study found that Verquvo reduced deaths from heart and circulation problems or hospital admissions for heart failure. Although the effect compared to placebo was modest, it was considered significant considering that the patients included in the study were at high risk of hospitalisation or death. The safety of Verquvo was considered acceptable and the medicine well-tolerated. The European Medicines Agency therefore decided that Verquvo’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verquvo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Verquvo are continuously monitored. Suspected side effects reported with Verquvo are carefully evaluated and any necessary action taken to protect patients.
Verquvo received a marketing authorisation valid throughout the EU on 16 July 2021.
Product information
16/07/2021
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
- Verquvo
- Active substance
- Vericiguat
- International non-proprietary name (INN) or common name
- vericiguat
- Therapeutic area (MeSH)
- Heart Failure
- Anatomical therapeutic chemical (ATC) code
- C01
Pharmacotherapeutic group
Cardiac therapyTherapeutic indication
Treatment of symptomatic chronic heart failure
News on Verquvo
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