Xevudy (sotrovimab), developed by GlaxoSmithKline (GSK) and Vir Biotechnology, is the second monoclonal antibody treatment approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) after it approved Lagevrio (molnupiravir) last month.
The drug is administered by intravenous infusion over 30 minutes, and it is approved for people aged 12 and over and weighing more than 40 kg (88 pounds).
It’s authorised for use in people who have mild to moderate CCP (Chinese Communist Party) virus infection and at least one risk factor for developing severe illness, such as obesity, older age (55 years and over), diabetes mellitus, or heart disease.
MHRA said one dose of the single monoclonal antibody was found in a clinical trial to reduce the risk of hospitalisation and death by 79 percent in high-risk adults with symptomatic CCP virus infection.
The agency recommended using the drug within five days of symptom onset so it would be more effective.
Dr. June Raine, MHRA chief executive, said she’s “pleased to say that we now have another safe and effective COVID-19 treatment” 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,” Raine said.
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said the commission and its COVID-19 Therapeutics Expert Working Group had independently reviewed the data and agree with the MHRA’s regulatory approval of sotrovimab.
“Based on the data reviewed by the Commission and its expert group, it is clear sotrovimab is another safe and effective treatment to help us in our fight against COVID-19,” he said.
The drug is subject to additional monitoring so new safety information can be quickly identified, MHRA said, adding that healthcare professions are asked to report any suspected adverse reactions.
According to the regulator, the known risk of the drug is hypersensitivity reactions, including serious and/or life-threatening reactions.
MHRA also said there are currently no data on the use of sotrovimab during pregnancy, breast-feeding, or the effect of the drug on male or female fertility. Health professionals are advised to balance the potential treatment benefit of the mothers and the potential risks to the fetuses or breast-fed babies.
MHRA said it is too early to know whether the Omicron variant has any impact on sotrovimab’s effectiveness.
It comes as Vir Biotechnology published preclinical data on Thursday saying the new drug retains activity against key mutations of the Omicron variant.
The UK government has ordered around 100,000 doses of sotrovimab, and said the NHS will confirm how the treatment will be deployed in due course.
The government also said that the antibody treatment “is not intended to be used as a substitute for vaccination against COVID-19.”