Film-coated tablets for the treatment of chronic symptomatic heart failure in adults

About the medicinal product

Kerendia contains the active substance finerenone.

Swissmedic first authorised Kerendia on 26 November 2021 for the treatment of adults with chronic kidney disease and type 2 diabetes.

As a result of this indication extension, Kerendia can also be used to treat chronic symptomatic heart failure in adults with a left ventricular ejection fraction^[1] (LVEF) of 40% or more.

In patients with heart failure, the heart does not pump blood as effectively as the body needs. The heart is only able to fill with, and pump into the body, a smaller volume of blood than normal. This can cause symptoms such as shortness of breath, exhaustion and oedema.

The indication extension for Kerendia was authorised as part of the joint initiative of the Access Consortium.

This joint initiative is a collaborative project between the drug regulatory authorities in Australia (Therapeutic Goods Administration, TGA), Canada (Health Canada, HC), Singapore (Health Sciences Authority, HSA), the United Kingdom (Medicines & Healthcare products Regulatory Agency, MHRA), and Swissmedic. The joint initiative coordinates the assessment of authorisation applications for preparations with new active substances and indication extensions for these preparations that have been submitted in at least two of the five countries.

The application for indication extension for Kerendia was submitted to the drug regulatory authorities in Australia (Therapeutic Goods Administration, TGA), Canada (Health Canada, HC) and Switzerland. Each country assessed a part of the application and then shared and discussed the results. At the end of the process, each authority made its own, independent decision on whether to approve the indication extension.

Swissmedic considered the assessments of the foreign reference authorities in its decision.

The requirements for issuing a comprehensive SwissPAR (Swiss Public Assessment Report) and a Summary report on authorisation based on this SwissPAR have not been fulfilled. Swissmedic refers to the authorisation of the foreign reference authorities.

Further details of the Access joint initiative are published on the Swissmedic website: Access Consortium (swissmedic.ch).

^[1] _{Left ventricular ejection fraction (LVEF) is the volumetric percentage of blood that the left ventricle pumps into the body with each beat relative to the total volume of the ventricle.}

Further information on the medicinal product

Information for healthcare professionals: 

Information for patients (package leaflet): 

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}