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Glaxo (GSK)/ Vir Biotech COVID-19 Antibody Under Review in EU

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GlaxoSmithKline plc (GSK - Free Report) , along with its partner Vir Biotechnology, Inc. (VIR - Free Report) , announced that the European Medicines Agency (“EMA”) has started a review of their monoclonal antibody candidate, 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 who stands at high risk of progressing to severe COVID-19.

The review, being done by the EMA’s Committee for Human Medicinal Products, is based on safety and efficacy data from an interim analysis of phase III COMET-ICE study. The study is investigating VIR-7831 as a monotherapy for the early treatment of COVID-19 in adults who are at high risk of hospitalization.

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.

Last month, Glaxo and Vir Biotechnology submitted an application to the FDA requesting an Emergency Use Authorization (“EUA”) for VIR-7831 for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

Although VIR-7831 is yet to receive an approval or EUA for any indication, the candidate has demonstrated encouraging progress as monotherapy in a late-stage study. Interim data from the phase III COMET-ICE study evaluating VIR-7831 monotherapy for the early treatment of COVID-19 in adults who are at high risk of hospitalization showed that it led to 85% reduction in hospitalization or death as compared to placebo.

Shares of Glaxo have increased 2.4% so far this year against the industry’s decrease of 0.5%.

price chart for GSK


Notably, in March 2021, pharma giant Eli Lilly (LLY - Free Report) , along with Vir Biotechnology and Glaxo, announced positive top-line data from the expanded phase II study — BLAZE-4 — evaluating a cocktail of two antibodies in low-risk adult patients with mild-to-moderate COVID-19. The study evaluated 700mg of Lilly’s bamlanivimab (LY-CoV555) co-administered with 500mg of VIR-7831.

In February, Eli Lilly announced a deal with Vir Biotechnology and Glaxo to develop the combination therapy for certain COVID-19 patient.

Meanwhile, reportedly, activist investment firm Elliott Management Corp. is said to have bought a significant stake in GlaxoSmithKline. The company's shares rose in response on Thursday.

Zacks Rank & Key Pick

Glaxo currently carries a Zacks Rank #5 (Strong Sell).

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 5.2% upward for 2021 and 4.2% upward for 2022 over the past 60 days.

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