European Medicines Association’s human medicines committee has completed its review on the use of the monoclonal antibody sotrovimab – also known as VIR-7831 and GSK4182136 – to treat patients with Covid-19.
This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisaton.
The Agency concluded that sotrovimab can be used to treat confirmed Covid-19 in adults and adolescents – aged 12 years and above and weighing at least 40 kg – who do not require supplemental oxygen therapy.
And who are at risk of progressing to severe Covid-19. The medicine is given by infusion into a vein.
EMA made its recommendations following a review of data, including data on quality and from a study into the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms who do not need supplemental oxygen.
A planned interim analysis of this study indicated that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared with placebo: hospitalisation for more than 24 hours or death occurred in 1% (3 out of 291) of patients who received sotrovimab and 7% (21 out of 292) of those who received placebo.
In terms of safety, most side effects reported were mild or moderate.
