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Regkirona
ARTGs
N/A
Device/Product name
Regkirona
Active Ingredient
Regdanvimab
Date of decision
Published
Submission type
New biological entity
Decision
Approved for provisional registration
What was the decision based on
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 Regkirona was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Positive Designation (Provisional) | 20 August 2021 |
| Submission dossier accepted and first round evaluation commenced | 6 September 2021 |
| Evaluation completed | 25 November 2021 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 10 November 2021 |
| Sponsor’s pre-Advisory Committee response | 15 November 2021 |
| Registration decision (Outcome) | 6 December 2021 |
| Completion of administrative activities and registration on the ARTG | 6 December 2021 |
| Advisory Committee meeting | 18 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 65 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
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
Dose forms
Concentrate for solution for infusion
Strength
60 mg/mL
Other ingredients
Histidine, histidine hydrochloride monohydrate, polysorbate 80, arginine hydrochloride, water for injections
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous (infusion)
Dosage
Regkirona (regdanvimab) should be given as part of risk stratification of patients the pivotal consideration is the comorbidities, alongside age, particularly multiple comorbidities.
Regkirona (regdanvimab) should not be used in patients hospitalised due to COVID-19.
The recommended dosage of Regkirona (regdanvimab) in adults is a single intravenous infusion of 40 mg per kg bodyweight. The maximum dosage of Regkirona (regdanvimab) should not exceed 8000 mg.
For further information regarding dosage, refer to the Product Information.
Pregnancy category
B2Drugs 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.
What was approved
Regkirona (regdanvimab) was approved for the following therapeutic use:
Regkirona has provisional approval for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 (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 assessment.
What is this medicine and how does it work
Regdanvimab is a recombinant human immunoglobin G, subclass 1(IgG1) monoclonal antibody that binds to the receptor binding domain (RBD) of the spike(s) protein of severe acute respiratory syndrome coronavirus (SARS-CoV-2) consequently blocking SARS-CoV-2 cell entry and infection.
What post-market commitments will the sponsor undertake
- Regkirona is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicine Information (CMI) for Regkirona 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 Regkirona European Union (EU)-risk management plan (RMP) (version 0.5, dated 27 September 2021 according to Australian specific annex (ASA) v3.0, data lock point (DLP) 24 September 2021), with ASA (version 3.0, dated 21 October 2021), included with Submission PM-2021-04004-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of RMP 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 90 calendar days of the DLP for that report.
Additional to the submission of PSURs, expedited Regkirona 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.
- Clinical
- The sponsor must provide updates to the TGA regarding the clinical activity, efficacy, and effectiveness of Regkirona against the current and future variants of concern (VoC) and variants of interest (VoI) identified by the World Health Organisation (WHO).
- When available, further data relating to efficacy in immunocompromised subjects, pregnant women, lactating mothers, paediatric subjects, long term safety and the information relating to post-market safety and effectiveness studies should be provided to the TGA to update the PI.
- 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 3.0 (dated 21 October 2021) of the ASA. The following study report(s) should be submitted to TGA:
- Study CT-P-59 3.2 Part 2
Further guidance for sponsors is available on the TGA website.
- Quality
Post approval commitments:
- The sponsor will submit up to 12 months of acceptable stability data for the drug substance manufactured at Celltrion (CLT1) to the TGA by 10 December 2021.
- The sponsor will complete all ongoing stability studies and report any confirmed out of specification result and proposed remediation approaches to the TGA immediately.
- Laboratory testing and compliance with Certified Product Details – All batches of Regkirona 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 CPD, as described in Guidance 7: certified product details of the Australian regulatory guidelines for prescription medicines (ARGPM) http://www.tga.gov.au/industry/pm-argpm-guidance-7..., 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 PI must be included with the product as a package insert.