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Xevudy (sotrovimab) approved by MHRA for mild to moderate COVID-19

2nd December 2021

Xevudy (sotrovimab) reduces hospitalisations and death and has been approved by the MHRA for mild to moderate COVID-19 infection

Xevudy (sotrovimab) which is a monoclonal antibody, has been approved by the UK regulator, the MHRA, after data showing that it can reduce the risk of hospitalisation and death in people with mild to moderate COVID-19 infection and who are at an increased risk of developing severe disease.

According to a press release by the manufacturer, GSK who developed the drug in collaboration with Vir Biotechnology, Inc, Xevudy binds to an epitope on COVID-19 shared with SARS-CoV-1 (the virus responsible for SARS). This suggests that the particular epitope is highly conserved and may therefore be less susceptible to mutations and hence development resistance to the therapy.

Clinical efficacy

The manufacturer has embarked on several clinical trials with Xevudy which have included COMET-ICE, which was a phase 3, multi-centre, double-blind, placebo-controlled trial investigated sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalised and not requiring oxygen.

COMET-TAIL another phase 3 randomised, multi-centre, open label, non-inferiority trial for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalised adult and paediatric patients (12 years of age and older).

Interim results from COMET-ICE have been published in which 583 non-hospitalised, symptomatic COVID-19 patients were randomised, 1:1, less than 5 days after the onset of symptoms and with at least one risk factor for disease progression. Treatment consisted of a single infusion of sotrovimab at a dose of 500 mg or placebo. The results showed that 3 patients (1%) in the sotrovimab group and 21 patients (7%) in the placebo group, had disease progression leading to hospitalisation or death, giving a relative risk reduction of 85% (95% CI 44% – 96%, p = 0.002).

The full results of the COMET-ICE, which included 1057 patients showed that all-cause hospitalisation lasting over 24 hours, or death was significantly reduced with sotrovimab (1%) vs placebo (6%), giving an adjusted relative risk reduction of 0.79 (95% CI, 50% – 91%, p <.001). In other words, Xevudy reduced the risk of hospitalisations for longer than 24 hours or death by 79%.

According to the SPC, Xevudy is indicated for ‘the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection.’ It should be given as a single 500 mg dose and the SPC adds that ‘It is recommended that Xevudy is administered within 5 days of onset of symptoms of COVID-19.’

In a statement by the MHRA, it is noted that currently, it is uncertain whether the drug is effective against the omicron variant.

Source. MHRA Press release, 2nd December 2021