The monoclonal antibody treatment Xevudy has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in people with mild to moderate COVID-19 who are at high risk of developing severe disease.
Prof Penny Ward, Independent Pharmaceutical Physician, Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“Good news this morning from MHRA on the conditional approval for sotrovimab. In the phase III clinical trial COMET-ICE, sotrovimab, given within 5 days of first onset of symptoms, reduced the rate of hospitalisation and death among a population of high risk patients from 6% to 1%, with an adjusted proportionate reduction of 79% mostly driven by a reduced need for hospitalisation. There were few deaths in the study, but 2 were in the placebo group and 1 in the sotrovimab group. Sotrovimab is given by IV infusion over 30 minutes. Side effects are limited to infusion reactions which may rarely include anaphylaxis, and so must be given in a setting where resuscitation facilities are available. This can be challenging for community use, but not impossible to administer in infusion hubs, hospital outpatient facilities etc. Perhaps of greater importance, the product was designed to bind to a highly conserved portion of the spike protein, making it less susceptible to mutations. Initial information demonstrates broad activity against most variants. As some of these share some (but not all) of the mutations noted in the omicron variant it is reasonable to anticipate that it may retain antiviral effect against this strain also. However this needs to be formally demonstrated in vitro. It is understood that the UK has 100,000 doses on order which is a very limited supply. The NHS has yet to announce how it will be deployed. A similar product, Ronapreve, was restricted to use for hospitalised patients, based on data from the RECOVERY trial, in which it reduced mortality in hospitalised patients that were seronegative (did not have any covid antibody) on admission. Although sotrovimab has not been investigated in the Recovery trial, it is possible that given the need for IV administration, it may be similarly restricted.”
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Prof Penny Ward: “I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”