Livtencity
Registration timeline
The following table summarises the key steps and dates for this application, evaluated through Priority Review.
|
Description |
Date |
|
Positive Designation (Orphan) |
21 October 2021 |
|
Submission dossier accepted and first round evaluation commenced |
17 January 2022 |
|
Evaluation completed |
24 June 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
4 July 2022 |
|
Sponsor’s pre-Advisory Committee response |
18 July 2022 |
|
Advisory Committee meeting |
4 and 5 August 2022 |
|
Registration decision (Outcome) |
27 September 2022 |
|
Completion of administrative activities and registration on ARTG |
7 October 2022 |
|
Number of working days from submission dossier acceptance to registration decision* |
155 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
Tablet core: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Film coating: Brilliant blue FCF aluminium lake (FD&C Blue #1), macrogol (polyethylene glycol), polyvinyl alcohol, purified talc, titanium dioxide
The recommended dose of Livtencity is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg. Treatment duration may need to be individualised based on the clinical characteristics of each patient.
For further information refer to the Product Information.
Drugs 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.
Livtencity (maribavir) was approved for the following therapeutic use:
Treatment of adults with post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies (see 4.3 Contraindications and, 4.4 Special warnings and precautions for use).
- Livtencity (maribavir) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Livtencity 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 Livtencity EU [European Union]-risk management plan (RMP) (version 0.1, date 12 April 2021; DLP [data lock point] 17 December 2020), with Australia specific Annex (version 1.0, dated 1 December 2021), included with Submission PM-2021-05396-1-2, 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 (revision 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 ninety calendar days of the data lock point for that report.