Britain's drug regulator has approved GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology's (NASDAQ:VIR) antibody based COVID-19 treatment, Xevudy (sotrovimab), for people with mild-to-moderate COVID-19 who are at high risk of developing severe disease.
In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalization and death by 79% in high-risk adults with symptomatic COVID-19.
The Medicines and Healthcare products Regulatory Agency (MHRA) recommends that sotrovimab should be given within five days of symptoms developing, as it is proven to be most effective in the early stages of infection.
It is the second antibody therapeutic to receive approval in U.K., three months after Ronapreve, which is produced by Regeneron/Roche, became the first.
Unlike molnupiravir, sotrovimab is administered by intravenous infusion over 30 minutes. It is approved for individuals aged 12 and above who weigh more than 40kg.
Announcing the drug’s approval, Dr June Raine, the chief executive of the MHRA, said: “I am pleased to say that we now have another safe and effective Covid-19 treatment, Xevudy (sotrovimab), for those at risk of developing severe illness."
“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.”