TGA provisionally approves GlaxoSmithKline's COVID-19 treatment: sotrovimab (XEVUDY)

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.

The TGA has published a series of regulatory documents that relate to this decision, including the Australian Public Assessment Report (AusPAR), Product Information and the decision summary, which provide details about the evidence that the TGA reviewed to support the provisional approval of this treatment.

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