MedPath
EMA Approval

Kerendia

C09

作用于肾素-血管紧张素系统的药物

Agents acting on the renin-angiotensin system

finerenone

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Basic Information

C09

作用于肾素-血管紧张素系统的药物

Agents acting on the renin-angiotensin system

Therapeutic indication

Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Overview Summary

Kerendia is a medicine used to treat chronic kidney disease in adults with type 2 diabetes.

It is used for patients with moderate or severe kidney damage who pass albumin (a type of protein) in their urine.

Kerendia contains the active substance finerenone.

Authorisations (1)

EMEA/H/C/005200

Bayer AG,51368 Leverkusen,Germany

Authorised

February 16, 2022

Active Substances (2)

Finerenone

Finerenone

Documents (11)

Kerendia : EPAR - Medicine Overview

March 11, 2022

OVERVIEW_DOCUMENT

Kerendia : EPAR - Risk management plan summary

March 11, 2022

RISK_MANAGEMENT_PLAN_SUMMARY

Kerendia : EPAR - All authorised presentations

March 11, 2022

AUTHORISED_PRESENTATIONS

Kerendia : EPAR - Public Assessment Report

March 11, 2022

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Kerendia : EPAR - Public Assessment Report

March 11, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of opinion for Kerendia

December 17, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Kerendia : EPAR - Procedural steps taken and scientific information after authorisation

February 20, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Kerendia : H-C-5200-II-0001-G : EPAR - Assessment report - Variation

February 20, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP post-authorisation summary of positive opinion for Kerendia (II-01-G)

December 16, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of opinion for Kerendia

December 17, 2021

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Kerendia : EPAR - Product Information

March 11, 2022

DRUG_PRODUCT_INFORMATION

Overview Q&A (7)

Question

What benefits of Kerendia have been shown in studies?

Answer

Kerendia, in addition to standard treatment, was shown to be effective at slowing down kidney disease in one main study involving over 5,600 patients with chronic kidney disease and type 2 diabetes. In this study, 18% of patients taking Kerendia (504 out of 2,833) experienced a loss of kidney function compared with 21% of patients taking a placebo, or dummy treatment, (600 out of 2,841).

Question

How is Kerendia used?

Answer

Kerendia can only be obtained with a prescription.

Kerendia is available as tablets to be taken by mouth once a day. The dosage to be taken depends on the patient’s kidney function.

For more information about using Kerendia, see the package leaflet or contact your doctor or pharmacist.

Question

How does Kerendia work?

Answer

The active substance in Kerendia, finerenone, binds to a receptor (target) known as mineralocorticoid receptor (MR). MR is involved in the activation of processes that cause inflammation and scarring in the kidneys. By binding to MR, Kerendia blocks the start of these processes, preventing inflammation and scarring and leading to less kidney damage.

Question

What are the risks associated with Kerendia?

Answer

The most common side effect with Kerendia (which may affect more than 1 in 10 people) is the presence of high potassium levels in the blood. Other common side effects, which may affect up to 1 in 10 people, are low levels of sodium in the blood, low blood pressure, itching and loss of kidney function.

Kerendia must not be used in patients with Addison’s disease (a condition that prevents the body from producing enough of the hormones cortisol and aldosterone). It must also not be used with certain medicines that strongly block the effects of CYP3A4, a liver enzyme that helps the body process many medicines.

For the full list of side effects and restrictions of Kerendia, see the package leaflet.

Question

Why is Kerendia authorised in the EU?

Answer

Kerendia was shown to slow down loss of kidney function in adults with chronic kidney disease and type 2 diabetes. Overall, the medicine’s side effects were considered manageable. Therefore, the European Medicines Agency decided that Kerendia’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Kerendia?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kerendia have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Kerendia are continuously monitored. Side effects reported with Kerendia are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Kerendia

Answer

Kerendia received a marketing authorisation valid throughout the EU on 16 February 2022.

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