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Zebinix
Sponsor
ARTGs
335289 and 335290
335289 and 335290
Device/Product name
Zebinix
Active Ingredient
Eslicarbazepine acetate
Date of decision
Published
Submission type
New chemical entity
ATC codes
N03AF04
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 Zebinix 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.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 June 2020 |
| First round evaluation completed | 20 November 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 19 January 2021 |
| Second round evaluation completed | 5 May 2021 |
| Delegate's overall benefit-risk assessment | 26 April 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 10 May 2021 |
| Completion of administrative activities and registration on ARTG | 18 May 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 196 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
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
Tablet
Strength
200 mg and 800 mg
Other ingredients
Povidone, croscarmellose sodium and magnesium stearate
Containers
Blister pack
Pack sizes
200 mg: 20 and 60 tablets800 mg: 20, 30, 60, 90 and 180 tablets
Routes of administration
Oral
Dosage
Adults
Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200 mg once daily. Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see Section 5.1 pharmacodynamic properties in the Product Information).
Paediatric population
Children above 6 years of age:
The recommended starting dose is 10 mg/kg/day once daily. Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day, based on individual response. The maximum dose is 1,200 mg once daily (see Section 5.1 pharmacodynamic properties in the Product Information).
Children with a body weight of ≥ 60 kg:
Children with a body weight of 60 kg or more should be given the same dose as for adults.
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
Zebinix (eslicarbazepine acetate) was approved for the following therapeutic use:
Zebinix is indicated as:
- monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
- adjunctive therapy in adults, adolescents and children aged above 6 years, with partial- onset seizures with or without secondary generalisation.
What is this medicine and how does it work
The precise mechanisms of action of eslicarbazepine acetate are unknown. However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing.
What post-market commitments will the sponsor undertake
- Zebinix (eslicarbazepine acetate) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Zebinix 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 Zebinix European Union (EU)-Risk Management Plan (RMP) (version 22.0, dated 2 March 2017, data lock point 21 October 2015), with Australian Specific Annex (version 2.0, dated 7 December 2020), included with submission PM-2020-01850-1-1, 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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.