GSK seeks TGA approval for high dose of COVID therapy as current dose not protecting against Omicron

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

GSK’s monoclonal antibody treatment was provisionally approved by the TGA for the treatment of adults and adolescents (aged 12 years and over) 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.

On 5 April, the US Food and Drug Administration (FDA) revoked the authorisation of Xevudy. Available clinical data, based on antibody neutralisation activity, has suggested that the 500 mg dose is not effective in neutralising the Omicron BA.2 variant, which is now dominant in Australia and many other countries.

GSK have now submitted data to the TGA to support the proposed use of a single 1000 mg dose of Xevudy for patients suspected of having infection with Omicron BA.2.

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