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Kerendia
Sponsor
ARTGs
350772, 350773
350772, 350773
Device/Product name
Kerendia
Active Ingredient
Finerenone
Date of decision
Published
ATC codes
Not yet assigned
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Kerendia was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium, with work-sharing between TGA, Health Sciences Authority Singapore and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 4 January 2021 |
| First round evaluation completed | 30 April 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 28 June 2021 |
| Second round evaluation completed | 19 August 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 September 2021 |
| Sponsor's pre-Advisory Committee response | 14 September 2021 |
| Advisory Committee meeting | 30 September 2021 and 1 October 2021 |
| Registration decision (Outcome) | 18 November 2021 |
| Completion of administrative activities and registration on ARTG | 25 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 181 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Film coated tablets
Strength
10 mg and 20 mg
Other ingredients
Croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, iron oxide red (for the 10 mg tablet), iron oxide yellow (for the 20 mg tablet)
Containers
Blister pack
Pack sizes
14, 28, 98, 100
Routes of administration
Oral
Dosage
The recommended target dose of Kerendia is 20 mg once daily.
Dosage is based on multiple factors, including serum potassium level, estimated glomerular filtration rate and pre-existing conditions of the patient (see Section 4.4 Special warnings and precautions for use of the Product Information).
For further information refer to the Product Information.
Pregnancy category
DDrugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Kerendia (finerenone) was approved for the following therapeutic use:
Kerendia is indicated to delay progressive decline of kidney function in adults with chronic kidney disease associated with Type 2 diabetes (with albuminuria), in addition to standard of care (see Section 5.1 Pharmacodynamic properties, clinical trials).
What is this medicine and how does it work
Finerenone is a nonsteroidal antagonist of the mineralocorticoid receptor (MR) that potently attenuates inflammation and fibrosis mediated by MR overactivation. The MR is expressed in the kidneys, heart and blood vessels where finerenone also counteracts sodium retention and hypertrophic processes. Finerenone has high selectivity for the MR due to its nonsteroidal structure and bulky binding mode. Finerenone has no relevant affinity for androgen, progesterone, estrogen and glucocorticoid receptors and therefore does not cause sex hormone related adverse events (for example, gynecomastia). Its binding to the MR leads to a specific receptor ligand complex that blocks recruitment of transcriptional coactivators implicated in the expression of pro-inflammatory and pro-fibrotic mediators.
What post-market commitments will the sponsor undertake
- Kerendia (finerenone) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Kerendia must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Kerendia European Union (EU)-risk management plan (RMP) (version 0.1, dated 22 October 2020; data lock point (DLP) 15 October 2020) and Australia specific annex (ASA) (version 1.0, dated 6 November 2020) included with Submission PM-2020-05944-1-5, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s guideline on Good Pharmacovigilance Practices (GVP) module VII-periodic safety update report (rev 1), part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within 90 calendar days of the DLP for that report.