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Covid-19: Has the spread of omicron BA.2 made antibody treatments redundant?


Drug regulators are reviewing authorisations for monoclonal antibody treatments just months after they were issued. Elisabeth Mahase asks what the future holds for this class of biologicals The US Food and Drug Administration has removed its authorisation for anti-SARS-CoV-2 monoclonal antibody treatment sotrovimab because of concerns that it is ineffective against the omicron subvariant BA.2, which is now dominant in the US. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) authorised sotrovimab for high risk over 12s with mild to moderate covid-19 in December 20212 after reporting that a single dose, given as an intravenous infusion over 30 minutes, reduced the risk of hospital admission and death by 79% in high risk adults with symptomatic covid-19. The regulator has told The BMJ that it is also now reviewing the treatment to see if the “benefit-risk balance remains favourable.” Laura Squire, the MHRA’s chief officer for healthcare access and quality, said, “We are in contact with the FDA and are looking closely at the data supporting their decision.”

The BMJ - April 21, 2022

View the full story here: https://www.bmj.com/content/377/bmj.o1009