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Glaxo (GSK), Vir Seek EUA for Intramuscular Sotrovimab in US

GlaxoSmithKline GSK and Vir Biotechnology VIR recently announced the submission of a regulatory application to the FDA seeking emergency use authorization for intramuscular (“IM”) administration of their antibody COVID-19 drug candidate, sotrovimab (Xevudy), as a potential early treatment of COVID-19.

The drug candidate is already approved or authorized for emergency/conditional use in the United States, Europe and some other countries as a single-dose intravenous (“IV”) administration. Under the current EUA from the FDA, sotrovimab’s IV administration is available as early treatment for mild-to-moderate COVID-19 in positive adults as well as pediatric patients aged 12 years or older, who are at high risk of progression to severe COVID-19, including hospitalization or death.

The submission of the new EUA application for IM administration is based on data from the phase III study — COMET-TAIL. Data from the study demonstrated that the IM administration of the candidate was non-inferior to the IV administration in reducing hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease.

Please note that the IV administration was granted EUA based on data from the phase III study — COMET-ICE — which demonstrated that IV administration of sotrovimab achieved an 85% reduction in hospitalization or death. In-vitro data had shown that sotrovimab maintains activity against all known variants of concern

In December 2021, Glaxo and Vir announced pre-clinical data, which demonstrated that sotrovimab, maintains activity against key mutations in the spike protein of the new variant of concern, Omicron.

For the trailing 12 months, Glaxo’s shares have risen 17.9% compared with the industry’s 17% increase.

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Shares of Vir have risen 3.2% in the same period against the industry’s 32.4% decline.

Image Source: Zacks Investment Research

Glaxo and Vir signed a supply agreement with the U.S. government last year for sotrovimab doses for approximately $1 billion. Earlier this week, the companies signed a new agreement with the federal government for the supply of an additional 600,000 doses with options for more doses. Glaxo and Vir have secured agreements with various entities across the world to supply nearly 1.7 million doses of sotrovimab.

While sotravimab holds promise, it faces stiff competition from other monoclonal antibodies developed by Eli Lilly LLY and Regeneron REGN.

Lilly’s COVID-19 antibody cocktail comprises two monoclonal antibodies, bamlanivimab and etesevimab, which were initially granted EUA by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk adult and pediatric patients (aged at least 12 years and weighing at least 40 kg). The EUA was later expanded to include all pediatric patients including newborns.

Lilly’s COVID-19 therapeutics generated revenues of $1.18 billion in the first nine months of 2021.

Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab. It was granted EUA by the FDA in November 2020 to treat mild-to-moderate COVID-19 in high-risk adults and pediatric patients (aged at least 12 years and weighing at least 40 kg).

Sales from REGEN-COV have become a significant contributor to Regeneron’s overall top line in the recent quarters. For the first nine months of 2021, Regeneron recorded $4.7 billion in sales from REGEN-COV.

Both Lilly and Regeneron’s antibody cocktails have also received EUA from the FDA as post-exposure prevention (prophylaxis) for COVID-19 indication.

Zacks Rank

Glaxo currently has a Zacks Rank #3 (Hold) while Vir sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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