Jivi
Registration timeline
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced |
31 March 2022 |
|
First round evaluation completed |
19 July 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
16 September 2022 |
|
Second round evaluation completed |
21 October 2022 |
|
Delegate’s Overall benefit-risk assessment |
24 January 2023 |
|
Sponsor’s pre-Advisory Committee response |
Not applicable |
|
Advisory Committee meeting |
Not applicable |
|
Registration decision (Outcome) |
21 March 2023 |
|
Completion of administrative activities and registration on ARTG |
27 March 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
165 |
* The COR-B process has a 175 working day evaluation and decision timeframe.
Powder for injection: Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80 and glacial acetic acid
Prefilled syringe: Water for injections
The dose and duration of substitution therapy depends on the severity of the factor VIII deficiency, the location and extent of the bleeding and on the patient's clinical condition.
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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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
Jivi (damoctocog alfa pegol) was approved for the following therapeutic use:
Jivi, damoctocog alfa pegol, is a long-acting recombinant Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia A for:
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
- On-demand treatment and control of bleeding episodes
- Per-operative management of bleeding (surgical prophylaxis)
Jivi does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.
Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a X-chromosomal hereditary disorder of blood coagulation due to decreased levels or absence of factor VIII:C that results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Damoctocog alfa pegol is a PEGylated B-domain deleted recombinant human coagulation factor VIII (PEG-BDD-rFVIII). Site-specific PEGylation reduces clearance of factor VIII resulting in an extended half-life while maintaining the normal functions of the B-domain deleted rFVIII molecule. Damoctocog alfa pegol does not contain von Willebrand factor.
- Jivi (damoctocog alfa pegol) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Jivi 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 Jivi EU [European Union] Risk Management Plan (RMP) (version 2.1, dated 17 June 2021, data lock point 2 December 2020), with Australian Specific Annex (version 1.0, dated 3 February 2022), included with submission PM-2022-00347-1-6, 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 (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- Laboratory testing & compliance with Certified Product Details (CPD)
- All batches of Jivi damoctocog alfa pegol supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
- Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the Product Information must be included with the product as a package insert.