May 21, 2021
15:10
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The European Medicines Agency has recommended the use of the drug sotrovimab reducing the risk of hospitalization or death from coronavirus by 85%.
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the drug sotrovimab, intended to treat the coronavirus.
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Also known as VIR-7831 or GSK4182136, this treatment was developed by GlaxoSmithKline (GSK) and Vir Biotechnology. It attaches to the protuberances of the coronavirus and thus prevents it from entering the cells of the body. Sotrovimab is administered by intravenous infusion.
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Only 3 of the 291 subjects who received the drug were hospitalized and / or died. In the placebo group, this was the case for 21 out of 292 patients.
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This medicine can be used in all patients aged 12 and over who do not need supplemental oxygen and are unlikely to be seriously ill, according to the opinion of the EMA.
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However, the agency is not yet in a position to issue a marketing authorization, as a “continuous” review is still ongoing. The regulator said its decision was intended to provide scientific advice to national governments before full authorization.
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Drop in hospitalizations and deaths
This recommendation comes after an interim analysis of the drug showed that sotrovimab reduces the risk of hospitalization or death by 85% compared to a placebo. Alone 3 of 291 topics who received the drug were hospitalized and / or died. In the placebo group, this was the case for 21 out of 292 patients.
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The EMA also points out that most Side effects observed were mild or moderate. However, potential allergic reactions should be taken into account. It is not yet clear when the drug will receive its marketing authorization.
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