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Glaxo (GSK)/ Vir Biotech's COVID-19 Antibody Gets CHMP Nod

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GlaxoSmithKline plc (GSK - Free Report) along with partner Vir Biotechnology, Inc. (VIR - Free Report) , announced that the European Medicines Agency’s (“EMA”) Committee for Human Medicinal Products (“CHMP”) has rendered a positive scientific opinion related to the use of their monoclonal antibody candidate, sotrovimab (VIR-7831), for the early treatment of COVID-19.

The candidate is being evaluated for the treatment of adults and adolescents (aged 12 years and above and weighing minimum 40 kg) with COVID-19 who do not require oxygen supplementation and stand at high risk of progressing to severe COVID-19.

The CHMP’s opinion was based on an interim analysis of efficacy and safety data from a phase III COMET-ICE study on sotrovimab for the given indication. Interim data from the phase III COMET-ICE study showed that it led to 85% reduction in hospitalization or death as compared to placebo.

Shares of Glaxo have increased 5.5% so far this year compared with industry’s rise of 7.4%.

price chart for GSK


We remind investors that earlier this month, the EMA started a rolling review of data on sotrovimab for treating the given patient population. The rolling review will continue until enough data is obtained to support a formal filing of marketing authorization application in the EU.

Glaxo and Vir Biotechnology submitted an application to the FDA requesting an Emergency Use Authorization (“EUA”) for sotrovimab in March.

Please note that Glaxo and Vir Biotechnology are planning to submit a full marketing authorization application to the EMA for VIR-7831 based on the above study data.

We note that, Vir Biotechnology and Glaxo also have a deal with Eli Lilly (LLY - Free Report) , signed in February 2021, to develop a cocktail therapy combining 700mg of Lilly’s bamlanivimab plus 500mg of sotrovimab.

Zacks Rank & Key Pick

Glaxo currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Zoetis Inc. (ZTS - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Zoetis’ earnings estimates have been revised 1.5% upward for 2021 and 1.6% upward for 2022 over the past 60 days. The stock has gained 6.4% year to date.

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