The fate of antibody treatments for COVID-19 looks uncertain, with the FDA recently revoking the previously granted Emergency Use Authorization (EUA) to many of these in view of their lack of efficacy against the predominant Omicron variant in the United States.
Most of these treatments raked in significant sales in 2021 due to their widespread use, with the pandemic creating havoc. However, the recent data showing a lack of efficacy against the Omicron variant is a setback and will cause a dent in sales.
With the convenience of oral pills and increased vaccination rates, these treatments were likely to see a revision in sales from the highs of 2021. However, with the EUA being limited now, sales will be significantly impacted.
Vir Biotechnology, Inc. VIR and partner GlaxoSmithKline GSK recently received a jolt when the FDA determined that their investigational monoclonal antibody sotrovimab is no longer authorized for the treatment of COVID-19 given the absence of efficacy against the Omicron variant.
The regulatory body earlier amended the EUA for sotrovimab based on new data showing that it was unlikely that the sotrovimab 500 mg dose would be effective against the dominant Omicron BA.2 variant. The news was a big setback for Vir Biotechnology as the revision will impact sales. Vir Biotechnology reported collaboration revenues of $917.2 million in 2021 for the sale of sotrovimab under its 2020 partnership agreement with Glaxo.
Earlier, the FDA also revised the authorizations for two monoclonal antibody treatments – Eli Lilly’s LLY bamlanivimab and etesevimab (administered together) and Regeneron’s REGN REGEN-COV (casirivimab and imdevimab) – as data indicated that these treatments are highly unlikely to be active against the Omicron variant.
Sales of REGEN-COV had significantly boosted the top line of Regeneron, and this revision will adversely impact sales for now. Nevertheless, both these companies are extremely diversified and have other growth drivers, unlike Vir Biotechnology. Regeneron’s Eylea and Dupixent should maintain growth.
In February 2022, the FDA issued an EUA to Lilly’s bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Lilly has signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.
With the pandemic here to stay amid new rising variants despite increasing rates of vaccination, most of these companies are working on getting their treatments to work against the variant.
Regeneron is evaluating “next generation” antibodies that are active against Omicron, Delta (B.1.617.2), and other variants of concern. Both Vir Biotechnology and Glaxo are also preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant.
Last month, preclinical authentic ‘live’ virus data from Washington University School of Medicine demonstrated that AstraZeneca’s AZN Evusheld (tixagevimab co-packaged with cilgavimab) retains potent neutralizing activity against the Omicron SARS-CoV-2 BA.2 subvariant.
AstraZeneca’s Evusheld is authorized for pre-exposure prophylaxis (prevention) of COVID-19 in the United States and several other countries.
Vir Biotechnology currently carries 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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