Glaxo, Vir Covid Therapy Endorsed by Regulator for EU Use
(Bloomberg) -- A Covid-19 antibody treatment from GlaxoSmithKline Plc and Vir Biotechnology Inc. was endorsed by the European Union drug regulator for use in the region, clearing the way for another much-needed therapy.
The European Medicines Agency completed a review of the trial data and concluded the antibody -- VIR-7831 -- is a valid treatment option for adults and adolescents with a mild or moderate case who are at risk of the disease worsening, the regulator said Friday.
The EMA is also doing an expedited review of the product to support a possible full marketing authorization. The regulator said its decision Friday provides scientific guidance for national governments ahead of full approval.
The decision comes after interim data showed the drug reduced hospitalization or death by 85% compared with a placebo. In vitro studies showed the antibody remained active against a number of variants, including those originating in India and Brazil. Glaxo and Vir have also applied for a U.S. emergency use authorization, with a decision expected in coming weeks.
As “the virus generates new variants of concern, including those that recently emerged in India, the need for therapies that can slow the progression of disease” is a top priority, said Christopher Corsico, Glaxo’s head of development. “Antibody treatments are a critical part of a comprehensive solution to Covid-19, especially as less than 40% of adults across EU member states have received at least one dose of a vaccine to date.”
The EMA decision is based on efficacy data from 583 patients in a study in which enrollment was stopped early because of the clear benefits. Safety data is based on 868 patients, 63% of whom were Hispanic or Latino and 7% Black or African American. Those populations are roughly three times more likely to be hospitalized and two times more likely to die of Covid-19, according to the U.S. Centers for Disease Control and Prevention.
Glaxo and Vir also reported positive results in March for low-risk patients from a study combining their antibody treatment with a drug from Eli Lilly & Co. The cocktail of VIR-7831 with Lilly’s bamlanivimab reduced the amount of virus present in patients with mild-to-moderate Covid infection by 70% after seven days.
Not all trials have been successful. The companies halted a late-stage study in March looking at the effects of VIR-7831 in already hospitalized patients after an independent monitoring board raised concerns about the extent of the potential benefit.
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