PSAR interim authorisation of casirivimab and imdevimab 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 PSAR^* interim authorisation of casirivimab and imdevimab by Roche-Regeneron, to be administered together 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. Taking into consideration the limited indication of casirivimab and imdevimab as well as its limited efficacy and safety data at this time, the use of casirivimab and imdevimab is currently restricted to ID physicians.

The efficacy of casirivimab and imdevimab is based on the clinical data from the Phase III cohort of Study COV-2067, where a total of 4,567 adult ambulatory subjects aged ≥ 18 years were enrolled. These subjects had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms from within 7 days of randomisation, had oxygen saturation ≥ 93% on room air, were not on supplemental oxygen and were at risk of progressing to severe disease. The treatment with casirivimab and imdevimab demonstrated a 70% reduction in the relative risk for progression to a COVID-19-related hospitalisation or all-cause death compared to placebo, with a relative risk ratio of 0.30 (p = 0.002).

The safety analysis comprised data from 5,284 patients who were randomised in the Phase I/II and III cohorts of Study COV-2067. The adverse events of special interest (AESIs) in the study were infusion-related reactions, hypersensitivity reactions and AEs associated with medically-attended visits related to COVID-19. The incidences of AESIs were generally low and reported at similar incidence in the casirivimab-imdevimab group compared to the placebo group. Overall, the treatment with casirivimab-imdevimab 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 casirivimab and imdevimab and provide updates to healthcare professionals as necessary. Healthcare professionals are required to report any suspected serious adverse reactions observed with the use of casirivimab and imdevimab infusion to HSA. Please refer to the letter for details.

^* PSAR: Pandemic Special Access Route <https://www.hsa.gov.sg/hsa-psar> Published: 21 Sep 2021

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