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UK drug regulators approved antibody treatment for COVID-19, a disease caused by the CCP virus, on Thursday.
Developed by GlaxoSmithKline (GSK) and Vir Biotechnology, Xevudy (sotrovimab) is the second monoclonal antibody treatment. approved After approving Lagevrio (molnupiravir) last month, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.
The drug is given by intravenous drip over 30 minutes and is approved for people over the age of 12 who weigh more than 40 kg (88 pounds).
Allowed for use by people with mild to moderate CCP (Chinese Communist Party) viral infections and at least one risk factor for developing severe illnesses such as obesity, the elderly (55+), diabetes, and heart disease It has been.
According to MHRA, a single administration of a monoclonal antibody in clinical trials found a 79% reduction in the risk of hospitalization and death for high-risk adults with symptomatic CCP viral infections.
Authorities recommended using the drug within 5 days of the onset of symptoms to be more effective.
MHRA CEO Dr. June Raine said, “We are now receiving another safe and effective COVID-19 treatment for those at risk of developing a serious illness. I’m happy to say that. “
“Without compromising on quality, safety and effectiveness, the general public can trust that MHRA has performed a robust and thorough assessment of all available data,” Raine said. ..
Professor Sir Munir Pirmohamed, chair of the Human Medical Commission, said the Commission and its COVID-19 Treatment Expert Working Group independently reviewed the data and agreed to MHRA’s approval of the Sotrovimab Regulatory Authority.
“Based on data reviewed by the Commission and its group of experts, it is clear that sotrovimab is another safe and effective treatment to help fight COVID-19,” he said. ..
Drugs are subject to additional monitoring, allowing you to quickly identify new safety information. MHRA He added that medical professionals were required to report suspicious side effects.
According to regulators, a known risk of a drug is a hypersensitivity reaction, including serious and / or life-threatening reactions.
MHRA also stated that there are currently no data on the effects of the drug on the use of sotrovimab during pregnancy, lactation, or childbirth in men or women. Health professionals are advised to balance the potential therapeutic effects of the mother with the potential risks to the fetal or breastfed baby.
MHRA said it is premature to know if the Omicron variant has any effect on the efficacy of sotrovimab.
It comes as Vir biotechnology Preclinical data released Thursday that the new drug retains activity against significant mutations in the Omicron variant.
The UK government has ordered about 100,000 doses of sotrovimab, and the NHS said it would see how the treatment would eventually evolve.
The government also said that antibody therapy was “not intended to be used as an alternative to vaccination against COVID-19.”
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Lily Zhou is a freelance writer who mainly covers the British news of The Epoch Times.
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