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On 20 August 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional approval to GlaxoSmithKline (GSK) Australia Pty Ltd for its COVID-19 treatment-sotrovimab (XEVUDY)-making it the second COVID-19 treatment to receive regulatory approval in Australia. Australia is the first OECD country to issue a formal regulatory approval for sotrovimab (XEVUDY).
Sotrovimab (XEVUDY), a monoclonal antibody treatment, is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) 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.
Sotrovimab (XEVUDY) has been shown to reduce hospitalisation or death in patients with mild-to-moderate COVID-19 who do not require supplemental oxygen and are at high risk of progression to severe disease.
To date, sotrovimab (XEVUDY) has been granted interim or emergency authorisations in a number of jurisdictions including the United States, Canada and Singapore. The European Medicines Agency has also issued advice for the emergency use of sotrovimab (XEVUDY) while it is under regulatory review in Europe. The TGA continues to work very closely with international regulators to harmonise regulatory approaches, share information and where it speeds up evaluation, collaboratively review new treatments.
Australians can be confident that the TGA's review process of sotrovimab (XEVUDY) was rigorous. The decision to provisionally approve this treatment was also informed by expert advice from the Advisory Committee on Medicines (ACM), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.
The ACM discussed applying risk stratification when determining how sotrovimab (XEVUDY) should be used. The ACM agreed that the pivotal consideration is the existence of comorbidities rather than age, particularly multiple combinations of comorbidities, such as: diabetes requiring medication, obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, and asthma requiring medication. The ACM confirmed that sotrovimab (XEVUDY) should not be used in hospitalised patients or those who require oxygen therapy due to COVID-19. The ACM also reiterated its view that vaccination is the preferred and primary option to prevent COVID-19.
Provisional approval of this treatment is subject to certain strict conditions, such as the requirement for GSK Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety and ongoing post-market monitoring.
At this stage, the Australian Government has secured 7,700 doses of sotrovimab (XEVUDY) for the National Medical Stockpile. This is the first monoclonal antibody treatment for COVID-19 to be purchased by the Government, and more information about this procurement is available on the Department of Health's website.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product Information (PI)
- Advice on the use of sotrovimab (XEVUDY) vials post labelled expiry date
- Consumer Medicine Information (CMI)
- Sotrovimab (XEVUDY) Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG. - AusPAR: GlaxoSmithKline Australia Pty Ltd - sotrovimab (XEVUDY)
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. - Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021 (repealed)
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022
Advice on the use of sotrovimab (XEVUDY) vials post labelled expiry date
The Therapeutic Goods Administration (TGA) is advising that we have assessed that sotrovimab (XEVUDY) vials for the batch numbers below, can be used up to the revised expiry date, provided that approved storage conditions between 2°C to 8°C have been maintained.
| Batch number (LOT) | Label printed expiry date (EXP) | New expiry date |
|---|---|---|
| UK3F | 03/2022 | 09/2022 |
| JP9Y | 04/2022 | 10/2022 |
At the time of the initial provisional registration for sotrovimab (XEVUDY), the shelf-life was 12 months when stored at 2°C to 8°C. The TGA subsequently approved an application from the sponsor, GlaxoSmithKline Australia Pty Ltd (GSK), for an extension of shelf-life to 18 months when stored at 2°C to 8°C. This the current shelf-life.
GSK supplied some batches of sotrovimab (XEVUDY) to the Australian government before applying to the TGA for an extension of shelf-life. This means that the previously approved expiry date (of 12 months) appears on some batches of sotrovimab (XEVUDY) product labels. The labels associated with the specified batches above have not been amended to reflect the extended expiry date (of 18 months), however these batches can be used up to the revised expiry date.