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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|| |
Not yet assigned
Approved for provisional registration
|Date of decision|| |
20 August 2021
|Date of entry onto ARTG|| |
20 August 2021
|Original publication date|| |
20 August 2021
|ARTG numbers|| |
|Black Triangle Scheme|| |
Yes. As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration
GlaxoSmithKline Australia Pty Ltd
|Sponsor address|| |
Level 4, 436 Johnston Street, Abbotsford Victoria 3067
|Dose forms|| |
Concentrated injection solution for infusion
500 mg in 8 mL (62.5 mg/mL)
|Other ingredients|| |
Histidine, histidine hydrochloride monohydrate, sucrose, methionine, polysorbate 80 and water for injection.
|Pack sizes|| |
|Routes of administration|| |
Adults and adolescents (aged 12 years and older and weighing at least 40 kg)
The recommended regimen is a single 500 mg dose administered as an intravenous infusion.
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 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.
Xevudy (sotrovimab) was approved for the following therapeutic use:
Xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (see Section 5.1 Pharmacodynamic properties, clinical trials).
The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
The following table summarises the key steps and dates for this application.
Data was provided as a rolling submission. Under normal circumstances, TGA's assessment (for both provisional and general registration) begins once all information to support registration is available. As part of the Department of Health's response to the pandemic, the TGA has agreed to accept rolling data for COVID-19 vaccines, to enable early evaluation of data as it comes to hand.
|Designation (Provisional)||13 April 2021|
|Submission dossier accepted and first round evaluation commenced||20 May 2021|
|Evaluation completed||13 August 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||8 August 2021|
|Sponsor's pre-Advisory Committee response||10 August 2021|
|Advisory Committee meeting||12 August 2021|
|Registration decision (Outcome)||20 August 2021|
|Completion of administrative activities and registration on ARTG||20 August 2021|
|Number of working days from submission dossier acceptance to registration decision*||65|
*Statutory timeframe for standard applications is 255 working days
- Risk Management Plan
Sotrovimab (Xevudy) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xevudy must include the black triangle symbol and mandatory accompanying text for the period of provisional registration.
The Xevudy European Union (EU)-risk management plan (RMP) (version 1, undated, data lock point 27 April 2021), with Australian Specific Annex (version 1.2, dated 10 August 2021), included with submission PM-2021-01848-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
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 periodic safety update report (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.
Additional to the submission of PSURs, expedited Xevudy monthly summary safety reports (including safety data for patients in Australia and reporting of Australia specific safety concerns) are to be provided for the first 6 months post registration, and thereafter at intervals specified by the TGA.
- Laboratory testing & compliance with Certified Product Details (CPD)
- All batches of Xevudy sotrovimab 500 mg in 8 mL concentrated injection solution for infusion, glass vial 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.
The following study reports/data will have to be submitted before a definitive authorisation can be considered:
- Submit the final report/clinical study report for Study ‘COMET-ICE' with 24 weeks follow up duration when it becomes available.
- Submit the additional studies that are planned as part of the conditions for this provisional approval such as COVID-19 International Drug Pregnancy Registry, COMET-PACE Paediatric study, when available.
- When available, further data relating to efficacy, safety, and pharmacokinetics in paediatric and adolescent patients, pregnancy/lactation, immunocompromised patients, hepatic and renal failure, patients who have had a COVID-19 vaccine, and for repeat dosing. Safety data must be gathered and provided for paediatrics (through the COMET-PACE trial and Australian data) and pregnant/breastfeeding persons (through the COVID-19 International Drug Pregnancy Registry). Clinical trial and observational data should be collected to report on efficacy in this population, noting that both Study NCT04913675 (intramuscular versus intravenous Xevudy) and Study NCT04790786 (Xevudy versus other monoclonal antibodies) are currently enrolling participants aged 12 years and older. In vivo efficacy data needs to be collected against the delta and other variants. Ongoing data should also be collected on antibody-dependent enhancement, hypersensitivity reactions and other severe adverse drug events. Long term safety and the information relating to post-market safety and effectiveness studies should be provided to the TGA to update the Product information.
- Confirmatory trial data (as identified in the sponsor's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence) must be provided.
Specifically the sponsor must conduct studies as described in the clinical study plan in version 1.2 (dated 4 August 2021) of the Australia-Specific Annex. The following study report(s) should be submitted to TGA:
- Study VIR-7831-5001 (214367), (also known as COMET-ICE)
- Study 216912 (also known as COMET-PEAK)
- Study INSIGHT Protocol Number: 014/ACTIV-3-TICO (215149)
- Study VIR-7831-5008 (217114), (also known as COMET-TAIL)
- J2X-MC-PYAH (PYAH 05), (VIR-7831-5007), (also known as BLAZE-4)
- Paediatric study COMET-PACE
Further guidance for sponsors is available on the TGA website.
- Any out of specification result of stability data must be reported to TGA immediately.
- Medicine Labels
Unless otherwise agreed to by the Secretary following an application under section 9D of the Act, the product must only be supplied with the following labels:
- the international label as follows:
- carton label
- vial label
The sponsor will develop Australian-specific labels for the product, that conform with all relevant Australian labelling requirements, and will take all reasonable steps to implement such labelling before the end of the provisional registration period referred to in subsection 29(3) of the Act (being the period of 2 years starting on the day specified in the ARTG certificate of registration) (noting that, consistent with paragraph 28(5)(aaa) of the Act, changes to such matters as labels that have been agreed to as part of an evaluation under section 25 of the Act may only occur following submission under section 9D of a 'variation' application and approval by the TGA).
- the international label as follows:
- Post approval commitments:
- The sponsor will re-evaluate the specification limits of Xevudy and tighten the limits based on additional stability data and propose new limits to TGA by 17 April 2022.
- The sponsor will complete all ongoing stability studies and report any confirmed out of specification result and proposed remediation approaches to the TGA.
- For all injectable products the PI must be included with the product as a package insert.