Givlaari
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Designation (Orphan) | 12 October 2022 |
Submission dossier accepted and first round evaluation commenced | 31 January 2023
|
Delegate’s Overall benefit-risk assessment | 3 November 2023 |
Advisory Committee meeting | Not applicable |
Registration decision (Outcome) | 16 November 2023
|
Completion of administrative activities and registration on ARTG | 28 November 2023
|
Number of working days from submission dossier acceptance to registration decision* | 157
|
* The COR-B process has a 175 working day evaluation and decision timeframe.
Therapy should be initiated under the supervision of a healthcare professional experienced in the management of porphyria.
The recommended dose of Givlaari is 2.5 mg/kg once monthly, administered via subcutaneous injection. Dosing is based on actual body weight. The patient dose (in mg) and volume (in mL) should be calculated as follows:
Patient body weight (kg) × dose (2.5 mg/kg) = total amount (mg) of medicinal product to be administered. Total amount (mg) divided by vial concentration (189 mg/mL) = total volume of medicinal product (mL) to be injected.
For further information refer to the Product Information.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database 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.
Givlaari (givosiran) was approved for the following therapeutic use:
Givlaari is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
- Givlaari (givosiran) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Givlaari 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 Givlaari EU [European Union]-risk management plan (RMP) (version 2.0, dated 5 May 2022; DLP [data lock point] 19 November 2020), with Australia-specific annex (version 0.2, dated 20 June 2023), included with Submission PM-2022-05371-1-6, 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 ([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.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.