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Vir Biotechnology VIR and partner GlaxoSmithKline GSK announced that the FDA has granted Emergency Use Authorization (EUA) to their dual-action monoclonal antibody sotrovimab (previously VIR-7831) for high-risk COVID-19.
The EUA is for treating mild-to-moderate COVID-19 in adult and pediatric patients (at least 12 years of age and weighing at least 40) who are at risk of progression to severe COVID-19, including hospitalization or death.
The EUA submission was based on an interim analysis of efficacy and safety data from the phase III COMET-ICE study, which demonstrated an 85% reduction in hospitalization or death on treatment VIR-7831 in the above-mentioned patient population. Further, safety and efficacy data from the study at day 29 for the full population is expected to be presented in a few weeks’ time.
Meanwhile, in-vitro data has shown that sotrovimab maintains activity against all known variants of concern, including the Indian variant. A formal biologics license application (BLA) to the FDA is expected to be filed in the second half of 2021.
Meanwhile the European Medicines Agency (EMA) has also started a rolling review of data on sotrovimab. The rolling review will continue until enough data is obtained to support a formal filing of marketing authorization application in the EU.
Vir Biotech’s stock was up 9.3% in after-hours trading on May 26 in response to the news. The stock has risen 70.9% this year so far against the industry’s decrease of 5.4%.
So far this year, Glaxo’s shares have risen 5.2% compared with the industry’s 6.5% increase.
Other antibody drugs approved for emergency use for treating high-risk COVID-19 patients are Eli Lilly’s LLY cocktail therapy, bamlanivimab plus etesevimab and Regeneron’s REGN antibody cocktail, REGEN-COV (casirivimab and imdevimab).
Lilly generated revenues of $810.1 million from its COVID-19 therapies, bamlanivimab and its combination medicines in the first quarter. Please note that Lilly’s bamlanivimab was approved for treating COVID-19 as a monotherapy last year. However, demand for the drug fell short of management expectations. In April, Lilly requested the FDA to revoke the EUA granted to bamlanivimab as a monotherapy. Lilly will now focus only on supplying its antibody cocktail, bamlanivimab and etesevimab together, which was granted EUA in February this year. The FDA subsequently revoked the EUA for bamlanivimab alone.
Regeneron’s REGEN-COV recorded sales of $145.5 million in the first quarter.
While Vir Biotech has a Zacks Rank #4 (Sell), Glaxo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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