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Xevudy (sotrovimab) receives MHRA approval for mild to moderate COVID-19

Xevudy (sotrovimab) has been shown to reduce hospitalisations and death in mild to moderate COVID-19 and is now approved by the MHRA

Xevudy (sotrovimab) is a monoclonal antibody which has now 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 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 works by binding to an epitope on COVID-19 which is also present on SARS virus. As the SARS virus was in circulation several years ago, this finding 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 undertaken 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.

The interim results from COMET-ICE were published in the New England Journal of Medicine and included 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 with 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

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