Andexxa
Registration timeline
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced
|
30 June 2022 |
|
First round evaluation completed |
30 November 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
25 January 2023 |
|
Second round evaluation completed |
6 April 2023 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
1 May 2023 |
|
Sponsor’s pre-Advisory Committee response |
15 May 2023 |
|
Advisory Committee meeting |
1 and 2 June 2023 |
|
Registration decision (Outcome) |
27 June 2023 |
|
Completion of administrative activities and registration on ARTG |
3 July 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
206 |
*Statutory timeframe for standard applications is 255 working days
Trometamol, trometamol hydrochloride, arginine hydrochloride, sucrose, mannitol, and polysorbate 80.
Andexxa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes. The continuous infusion is to be administered within two minutes following the bolus dose.
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.
Andexxa (andexanet alfa) was provisionally approved for the following therapeutic use:
Andexxa (andexanet alfa) has provisional approval in Australia for adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The decision to approve this indication has been made on the basis of haemostatic efficacy and reduction in anti-FXa activity. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
Andexanet alfa is a specific reversal agent for FXa inhibitors. The predominant mechanism of action is the binding and sequestration of the FXa inhibitor. In addition, andexanet alfa has been observed to bind to, and inhibit tissue factor pathway inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor-initiated thrombin generation inducing a pro-coagulant effect.
- Andexxa (andexanet alfa) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Andexxa must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer.
- The Andexxa EU [European Union]-risk management plan (RMP) (version 3.0 succession 2.0 (date 7 November 2022; DLP [data lock point] 30 June 2022), with Australian specific annex (version 1.0 succession 3, date 10 May 2023), included with Submission PM‑2022‑01981‑1‑3, 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, or the entire period of provisional registration, whichever is longer.
- 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- The sponsor must conduct Study 18-513 (ANNEXA-I) and submit the study report to the TGA, as described in the clinical study plan in version 1.0 succession 3 (date 10 May 2023) of the Australia-specific annex.
- Laboratory testing & compliance with Certified Product Details (CPD)
- All batches of Andexxa 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.
- A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website [for the form] https://www.tga.gov.au/form/certified-product-details-cpd-biological-prescription-medicines [for the CPD guidance] https://www.tga.gov.au/guidance-7-certified-product-details
- It should be emailed to biochemistry.testing@tga.gov.au as a single PDF document.
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at the Australian Register of Therapeutic Goods (ARTG) search page.
Australian Public Assessment Reports (AusPARs) can be found at the AusPAR search page.
The latest news and updates regarding therapeutic goods regulation can be found at the TGA news page.