Interim authorisation of sotrovimab infusion for COVID-19 infection in Singapore

The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and Panel of Infectious Diseases (ID) Experts, would like to inform healthcare professionals on the interim authorisation of sotrovimab by GlaxoSmithKline-Vir Biotechnology under the Pandemic Special Access Route (PSAR) for the treatment of adult patients aged ≥ 18 years with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. This is the first SARS-CoV-2 monoclonal antibody to be granted interim authorisation under PSAR*. Taking into consideration the narrow use of sotrovimab as well as its limited efficacy and safety data at this time, the use of sotrovimab is currently restricted to ID physicians.

The efficacy of sotrovimab is based on the clinical data from the Phase III COMET-ICE Study, where a total of 1,057 adult subjects aged 18 to 96 years were enrolled. These subjects had mild-to-moderate COVID-19 symptoms within 5 days of symptoms onset, had oxygen saturation ≥ 94% on room air, were not on supplemental oxygen and were at risk of progressing to severe disease. The treatment with sotrovimab demonstrated a 79% reduction in the relative risk for progression to hospitalisation for acute treatment or death compared to placebo, with a relative risk ratio of 0.21 (p < 0.001).

The safety analysis comprised data from > 500 patients who had received sotrovimab and were followed through > 29 days. The common AEs reported were pneumonia, headache, dehydration, dyspnoea, nausea, and diarrhoea, all of which except diarrohea, were more frequently reported in the placebo group. Overall, the treatment with sotrovimab was well-tolerated with no significant safety signal detected in the Phase III clinical study.

HSA will continue to monitor the benefit-risk profile of sotrovimab and provide updates to healthcare professionals as necessary. Healthcare professionals are required to report any suspected serious adverse reactions observed with the use of sotrovimab to HSA. Please refer to the letter for details.

* PSAR https://www.hsa.gov.sg/hsa-psar Published: 30 Jun 2021

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