Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.
This follows a rigorous review of its safety, quality, and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the second monoclonal antibody therapeutic to be approved following Ronapreve, also known elsewhere as REGEN-COV and was developed by Roche (ROG: SIX) and Regneron (Nasdaq: REGN).
Developed by UK pharma major GlaxoSmithKline (LSE: GSK) and Vir Biotechnology (Nasdaq: VIR), sotrovimab is a single monoclonal antibody. The drug works by binding to the spike protein on the outside of the COVID-19 virus. This in turn prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.
Reduces the risk of hospitalization and death by 79%
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 infection.
Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.
Like Merck & Co’s molnupiravir, it has been authorized for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>55 years), diabetes mellitus, or heart disease.
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.
It is too early to know whether the omicron variant has any impact on sotrovimab’s effectiveness but the MHRA says it will work with the company to establish this.
Earlier this month, GSK and Vir won US government contracts totaling around $1 billion to purchase sotrovimab. The US Food and Drug Administration granted Emergency Use Authorization (EUA) for sotrovimab in May 2021.
Recently, GSK and Vir were awarded contracts worth more than $1 billion for the purchase of sotrovimab from the US government.
Sotrovimab’s Emergency Use Authorization (EUA) was approved by the US Food and Drug Administration in May 2021.