TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (XEVUDY) for the BA.2 Omicron sublineage

The Therapeutic Goods Administration (TGA) has received an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID 19 treatment, sotrovimab (XEVUDY). This higher dose will be considered for treatment of patients suspected to have infection caused by the Omicron BA.2 sublineage.

Currently, this monoclonal antibody treatment is provisionally approved by the TGA for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID 19 who do not require initiation of oxygen and who are at increased risk of progression to hospitalisation or death. The approved dose is 500 mg administered as an intravenous infusion.

Recent reports, based on antibody neutralisation activity, have suggested that the 500 mg dose is unlikely to be effective against the Omicron BA.2 sublineage, which is now dominant in Australia and many other countries. On 5 April, the US Food and Drug Administration revoked the authorisation of sotrovimab.

GSK have now submitted data to the TGA to support the proposed use of a single 1000 mg dose of sotrovimab for patients suspected of having infection with Omicron BA.2. As with all applications for COVID-19 treatments, the data will be assessed with the highest priority.

Sotrovimab (XEVUDY) is a monoclonal antibody treatment. Monoclonal antibodies are laboratory-made proteins that mimic our body's immune system to help fight off harmful viruses, such as SARS Cov-2. Further information on the treatments have been approved by the TGA for COVID-19 is available at COVID-19 treatments: Provisional registrations.

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