WHO advises against use of GSK/Vir, Regeneron COVID drugs, backs limited use of Gilead's remdesivir
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The World Health Organization in its updated guidelines recommended against the use of GSK (NYSE:GSK) and Vir Biotechnologys' (NASDAQ:VIR) sotrovimab and Regeneron Pharmaceuticals' (NASDAQ:REGN) antibody cocktail REGEN-COV (casirivimab- imdevimab) to treat patients with COVID-19.
Gilead Sciences' (NASDAQ:GILD) remdesivir was backed for use in patients with severe COVID-19 but the WHO panel made a conditional recommendation against the drug's use in patients with critical COVID-19.
The panel of the WHO said in the medical journal BMJ that data from in vitro SARS-CoV-2 neutralization assays, suggested that monoclonal antibodies (sotrovimab and casirivimab-imdevimab) are not effective for patients with non-severe COVID-19 in the current stage of the pandemic with the predominant Omicron variants.
The panel considered in vitro neutralization data showing that sotrovimab and REGEN-COV evaluated in trials meaningfully reduced neutralization activity of the currently circulating variants of the novel coronavirus and their subvariants. There was consensus among the panel that the absence of in vitro neutralization activity strongly suggested absence of clinical effectiveness of these monoclonal antibodies, said the WHO's Guideline Development Group (GDG).
Previously, the WHO had provided a conditional recommendation for sotrovimab's use for treating patients with non-severe COVID-19 at highest risk of hospitalization.
In March, the WHO had recommended casirivimab- imdevimab only for people who were not infected with Omicron as evidence suggested that the therapy was ineffective against the variant.
REGEN-COV is currently not being sold in the U.S. In January, the FDA had restricted the use of the treatment and in its Q2 earnings release in August, Regeneron noted that there were no sales of REGEN-COV in the U.S. during 2022.
In March, the U.S. government also paused the distribution of sotrovimab in certain states after the FDA amended its emergency use authorization noting the drug's weakness against Omicron subvariant.