Product Information update for COVID-19 treatment, XEVUDY (sotrovimab)

On 7 April 2022, the Therapeutic Goods Administration (TGA) announced receipt of an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID-19 treatment, XEVUDY (sotrovimab). This application is being considered for the treatment of patients suspected to have infection caused by the Omicron BA.2 sublineage, which has become the dominant strain of COVID-19.

The application from GSK followed reports suggesting that the provisionally approved 500 mg dose is unlikely to be effective against the Omicron BA.2 sublineage, and news that the United States Food and Drug Administration (US FDA) had revoked the authorisation of XEVUDY.

Current data continues to support the effectiveness of XEVUDY against the Omicron BA.1 and BA.1.1 sublineages. As such, the provisionally approved 500 mg dose of XEVUDY should continue to be administered to patients likely to have been infected with the Alpha, Beta, Omicron BA.1 or BA1.1 sublineages.

Based on advice from the Advisory Committee on Medicines, which met on 26 April 2022, the Product Information (PI) (pdf,180kb) document for XEVUDY has been updated to advise that it is uncertain if the approved dose (500 mg) of XEVUDY will be effective against the Omicron BA.2 sublineage.

In the meantime, the TGA is waiting on further data from the sponsor to support the efficacy of the higher (1000 mg) dose of XEVUDY against the Omicron BA.2 sublineage.

Contact for members of the media:

• Email: news@health.gov.au
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