Two COVID-19 antibody therapies are no longer recommended by the World Health Organization (WHO) because Omicron and the variant’s latest offshoots have likely rendered them obsolete.
The two therapies – designed to work by binding to the SARS-CoV-2 spike protein to neutralize the virus’s ability to infect cells – were among the first drugs developed at the start of the pandemic.
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The virus has evolved since then, and mounting evidence from laboratory tests suggests that the two therapies — both sotrovimab and casirivimab-imdevimab — have limited clinical activity against the latest iterations of the virus. As a result, they have also fallen out of favor with the US public health agency.
On Thursday, WHO experts said they strongly discourage use of the two therapies in patients with COVID-19, reversing previous conditional recommendations they supported as part of a series of recommendations published in the British Medical Journal.
GSK GSK.L and partner Vir Biotechnology’s VIR.O sotrovimab – which has generated billions in sales and has become one of the UK drugmaker’s best-selling products over the past year – was approved by the US Food and Drug Administration (FDA) in April taken market.
Given that the United States began questioning the clinical efficacy of sotrovimab against Omicron as early as February, the WHO’s finding comes a bit late, said Penny Ward, visiting professor of pharmaceutical medicine at King’s College London.
“Now that the WHO has issued this recommendation, it will be interesting to see how many other countries follow it,” she said.
Regeneron REGN.O and partner Roche’s ROG.S antibody cocktail casirivimab-imdevimab has also generated billions in sales and was one of the US drugmaker’s top sellers last year.
Back in January, the FDA revised its stance on the treatment, restricting its use to a smaller group of patients, citing its reduced effectiveness versus the Omicron variant.
Both therapies continue to be recommended for use by the European Medicines Agency.
Another COVID therapy that emerged early in the pandemic was Gilead’s antiviral remdesivir GILD.O. The WHO qualified its conditional recommendation for the drug, advising that it should only be used in patients with severe COVID due to its “modest” benefit.
There are a handful of existing COVID therapeutics that remain useful in the fight against the virus, and others in development that are expected to benefit patients as well.
(Reporting by Natalie Grover in London; Editing by Elaine Hardcastle)
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