13th Jan 2022 15:11
(Alliance News) - GlaxoSmithKline PLC on Thursday said it has submitted an application for emergency use authorisation for the intramuscular administration of Covid-19 drug sotrovimab in the US.
The Brentford, England-based pharmaceutical company, alongside San Francisco-based collaboration partner, Vir Biotechnology Inc, announced the submission to the US Food & Drug administration.
The application requests an amendment to the emergency use authorisation for sotrovimab, an investigational monoclonal antibody for the early treatment of Covid, to include intramuscular administration.
If authorised, it would provide the option for intramuscular administration of sotrovimab, in addition to currently authorised intravenous administration.
The emergency use authorisation for sotrovimab was granted in May of last year. Under the current legislation, sotrovimab can be used for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients.
On Tuesday, GSK announced that the US government will purchase 600,000 more doses of sotrovimab. The purchase agreement, an amendment to a deal announced in November, includes an option for further purchases by the US government in the second quarter of 2022. No details were provided about the value of the deal.
This comes after preclinical data in December showed the drug was effective on all variants of concern, including Delta and Omicron.
GSK and Vir have received binding agreements for roughly 1.7 million doses of the antibody across the world. They plan to manufacture around 2 million doses globally in the first half of 2022, and more in the second half.
GSK shares were down 0.4% at 1,629.80 pence each in London on Thursday afternoon.
By Greg Roxburgh; gregroxburgh@alliancenews.com
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