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Home / Companies / News /  GSK gets US clearance for covid antibody drug to treat 12 years and above

The US FDA has granted Emergency Use Authorisation for GlaxoSmithKline plc (GSK) & Vir Biotech's drug Sotrovimab to treat mild-to-moderate Covid-19 in high risk adults & paediatric patients.

The U.S. Food and Drug Administration cleared the drug, called VIR-7831 or sotrovimab, for people older than 12 with mild to moderate infection who are at risk of progressing to severe Covid-19, GSK said.

''GSK and Vir Biotechnology today announced the the US FDA granted an EUA for sotrovimab (previously VIR-7831), an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death,'' the statement said.

The companies applied for authorization in March based on interim data showing the drug reduced hospitalization or death by 85% compared with a placebo. Europe’s drugs regulator endorsed the treatment for use in May and is conducting an accelerated review of the product in parallel to potentially support a full marketing authorization.

In vitro data indicate sotrovimab maintains activity against all known variants of concern, including the variant from India, the companies said in a release. Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the U.S. in the coming weeks.

GSK added on to saying that discussions with global regulators regarding authorisations in additional countries continue to advance.


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