The US Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) Fact Sheet, limiting the usage of GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab for Covid-19, due to the BA.2 Omicron sub-variant.
As an investigational monoclonal antibody, sotrovimab attaches to the SARS-CoV-2 virus epitope to neutralise it.
Based on the totality of data available, including Vir’s new live virus findings, the currently authorised 500mg dose of the antibody is unlikely to be effective against the viral sub-variant, the FDA noted.
According to the latest FDA update, sotrovimab is not intended for usage in Maine, Massachusetts, Connecticut, Rhode Island, Vermont, New Jersey, New Hampshire, New York, Puerto Rico, and the Virgin Islands, US.
Sotrovimab is indicated for use in other regions until the regulatory authority issues further notice.
According to the previously issued FDA EUA, sotrovimab is intended to treat mild-to-moderate Covid-19 in adults and paediatric patients age 12 years and above, who are at increased risk of disease progression, including hospital admission or death.
The companies are currently compiling a data package that could back the usage of a higher dose of the antibody against the subvariant.
This package will be submitted to various regulatory and health agencies globally.
Sotrovimab has also obtained marketing authorisation from the European Commission, and conditional marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency, among others.
In a press statement, the FDA said: “We will continue to monitor BA.2 in all US regions and may revise the authorisation further, to ensure that patients with Covid-19 have effective treatments available.”