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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 chemical entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
Not yet assigned
Approved for provisional registration
|Date of decision|| |
10 July 2020
|Date of entry onto ARTG|| |
10 July 2020
|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.
Gilead Sciences Pty Ltd
|Sponsor address|| |
Level 6, 417 St Kilda Road, Melbourne, Victoria 3004
|Dose forms|| |
Concentrated injection, powder for injection
Concentrated injection: 100 mg/20 mL
Powder for injection: 100 mg
|Other ingredients|| |
Concentrated injection: sulfobutyl betadex sodium, hydrochloric acid, sodium hydroxide, water for injection.
Powder for injection: sulfobutyl betadex sodium, hydrochloric acid, sodium hydroxide.
|Pack sizes|| |
|Routes of administration|| |
Use of Veklury is confined to healthcare facilities in which patients can be monitored closely. Veklury is for single use in one patient only.
The recommended dosage of Veklury in patients 12 years of age and older and weighing at least 40 kg is:
The total duration of treatment should be at least 5 days and not more than 10 days. For further information on dosage, 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.
Veklury (remdesivir) was provisionally approved for the following therapeutic use:
Veklury has provisional approval for the treatment of Coronavirus Disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.
The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.
The provisional registration period for the above medicine is two years starting on the day specified in the Australian Register of Therapeutic Goods (ARTG) certificate of registration.
Remdesivir is an antiviral agent.
Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolised to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent ribonucleic acid (RNA) chains by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian deoxyribonucleic acid (DNA) and RNA polymerases with low potential for mitochondrial toxicity.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Veklury was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
International regulatory cooperation played a significant role, as the European Medicines Agency and the Singapore Health Sciences Authority shared their review reports with TGA at an early stage.
|Positive Designation (Provisional)||6 July 2020|
|Submission dossier accepted and first round evaluation commenced*||6 July 2020|
|Evaluation completed||8 July 2020|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||7 July 2020|
|Sponsor's pre-Advisory Committee response||8 July 2020|
|Advisory Committee meeting||9 July 2020|
|Registration decision (Outcome)||10 July 2020|
|Completion of administrative activities and registration on ARTG||10 July 2020|
|Number of working days from submission dossier acceptance to registration decision**||5|
*Some data was available during the pre submission assessment.
**Expedited evaluation of the submission was achieved through a large multidisciplinary review team at the TGA.
As a provisionally registered medicine, extensive post-market commitments are required of the sponsor. The following is a summary of the post-market commitments.
- Veklury (remdesivir) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Veklury must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- The Veklury European Union-risk management plan (EU-RMP; Version 1.0, dated 24 June 2020, data lock point 27 May 2020), with Australian specific Annex (version 0.1, dated 3 July 2020), included with submission PM-2020-01491-1-2, to be revised to the satisfaction of the TGA, and subsequent versions, 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.
- Additional to the submission of routine PSURs, the sponsor provides to the TGA expedited monthly remdesivir safety summary reports (including safety data for patients in Australia) for the first 6 months post registration, and thereafter at intervals specified by the TGA.
- 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 provide the study reports for studies as specified in Part III.2. Additional Pharmacovigilance activities of the Veklury EU-RMP (Version 1.0, dated 24 June 2020, data lock point 27 May 2020).
Clinical study reports (CSRs) for the following remdesivir studies/data should be submitted to the TGA, once available:
- Study GS-US-540-5773 (final CSR expected in December 2020 for Part A).
- Study GS-US-540-5774 (final CSR expected in December 2020 for Part A).
- Study CO-US-540-5776 (ACTT-I) (final CSR expected in December 2020).
- An analysis of all available safety data from clinical trials CO-US-540-5776, GS-US-5405773, GS-US-540-5774 and CO-US-540-5758 when completed, including case narratives, detailed information about adverse reaction and exposure data as well as an analysis of occurrence and aggravation of adverse events (AEs), serious adverse events (SAEs) and adverse drug reactions (ADRs) are associated with increasing exposure.
- Remdesivir pregnancy safety reports (yearly submission of annual reports).
- Phase I study in subjects with hepatic impairment (final CSR expected in November 2021).
- Phase I study in subjects with severe renal impairment and subjects with end stage renal disease on dialysis (final CSR expected in September 2021).
- The additional quality data requested should be provided to the TGA.
- The additional nonclinical data requested should be provided to the TGA.