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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
30 January 2020
|Date of entry onto ARTG|| |
5 February 2020
|ARTG numbers|| |
|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
Sanofi-Aventis Australia Pty Ltd
|Sponsor address|| |
12-24 Talavera Road, Macquarie Park, NSW 2113
|Dose forms|| |
Powder and solvent for solution for injection
|Other ingredients|| |
Powder: Sucrose, Citric acid, Sodium citrate dehydrate, Polysorbate 80
Solvent: Water for injections
Vial (powder) and prefilled syringe (solvent)
|Pack sizes|| |
|Routes of administration|| |
Intravenous injection, subcutaneous injection
Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
If at the end of this period there is evidence of unresolved immunological disease, it is recommended to optimise the immunosuppression regimen and continue daily subcutaneous administration of 10 mg of caplacizumab until the signs of underlying immunological disease are resolved (for example, sustained normalisation of ADAMTS13 activity level).
In the clinical development program, caplacizumab has been administered daily for up to 65 days. No data on re-treatment with caplacizumab are available.
For further information refer to the Product Information.
|Pregnancy category|| |
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 not shown 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.
Cablivi (caplacizumab) was approved for the following therapeutic use:
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
The following table summarises the key steps and dates for this Comparable Overseas Regulator pathway A (COR-A) application.
|Designation: Orphan||29 January 2019|
|Submission dossier accepted and first round evaluation commenced||1 July 2019|
|First round evaluation completed||30 September 2019|
|Sponsor provides responses on questions raised in first round evaluation||2 December 2019|
|Second round evaluation completed||2 January 2020|
|Delegate's overall benefit-risk assessment||16 January 2020|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||30 January 2020|
|Completion of administrative activities and registration on ARTG||5 February 2020|
|Number of working days from submission dossier acceptance to registration decision*||104|
*The evaluation and decision timeframe for COR-A applications is 120 working days.
- Cablivi (caplacizumab) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Cablivi 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.
- Batch release testing & compliance with Certified Product Details (CPD)
- It is a condition of registration that all batches of Cablivi (caplacizumab) imported into Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- It is a condition of registration that each batch of Cablivi (caplacizumab) imported into Australia is not released for sale until samples and/or the manufacturer’s release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results
- The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product. More information on TGA testing of biological medicines is available at Testing of biological medicines.
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor if notified in writing of any variation.
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.
CPDs should be emailed to Biochemistry.Testing@health.gov.au as a single PDF document.
- A condition of this registration will be that Study ALX0681-C302 is provided to TGA no later than it is submitted for evaluation to European Medicines Agency (EMA), United States (US) Food and Drug Administration (FDA) or Health Canada.
- The Cablivi European Union-Risk Management Plan (EU-RMP) (version 1.0, dated 31 August 2018, data lock point 6 March 2018), with Australian Specific Annex (version 1.0, dated 29 May 2019), included with submission PM-2019-02057-1-6, 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 this 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.