Other safety alerts
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| Canada: Bamlanivimab: Potential risk of treatment failure due to circulation of resistant SARS-CoV-2 variants |
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Health Canada announces that a potential risk of treatment failure of bamlanivimab against certain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants was identified through global surveillance. Bamlanivimab is expected to retain neutralizing activity against the United Kingdom (UK) origin B.1.1.7 variant.
Bamlanivimab was authorized for use in relation to the COVID-19 pandemic, in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. The The Canadian Product Monograph (CPM) for bamlanivimab was updated on 14 Apr 2021 with information concerning SARS-CoV-2 variants of concern.
Certain circulating SARS-CoV-2 viral variants may be associated with resistance to bamlanivimab. Evaluation of susceptibility of variants identified through global surveillance in subjects treated with bamlanivimab is ongoing. Antiviral activity of bamlanivimab against SARS-CoV-2 variants was evaluated using in vitro pseudovirus assays. Pseudovirus harboring the concurrent spike substitutions, present in the B.1.351 variant lineage (K417N + E484K + N501Y) first identified in South Africa, the P.1 variant lineage (K417T + E484K + N501Y) first identified in Brazil, B.1.427/B.1.429 variant lineage (L452R) first identified in California, and E484K containing B.1.526 variant lineage first identified in New York, exhibited reduced susceptibility to bamlanivimab. Bamlanivimab retained activity against pseudovirus expressing del69-70 + N501Y spike substitutions found in the UK origin B.1.1.7 variant lineage.
There is a potential risk of treatment failure with bamlanivimab due to resistant SARS-CoV-2 variants.
Healthcare professionals are advised that:
- The in vitro pseudovirus results indicate there will likely be limited or no clinical benefits with the use of bamlanivimab against SARS-CoV-2 viruses that contain the E484K mutation and/or the L452R mutation. Bamlanivimab is expected to retain clinical benefit against the UK origin B.1.1.7 variant.
- Local epidemiology of variants should be taken into consideration before empiric use of bamlanivimab as single monoclonal antibody therapy. Bamlanivimab should be used only in regions where there is known or confirmed low prevalence of lineages containing E484K (e.g., South Africa or Brazil origin) and/or L452R (e.g., California origin) SARS-CoV-2 variants, and if other monoclonal antibodies that retain neutralization activity across variants are not available.
- Patients treated with bamlanivimab should be monitored for COVID-19 signs and symptoms of infection and provided additional confirmation or treatment of disease where required.
- For further details regarding variants of concern, healthcare professionals should consult the CPM for bamlanivimab.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75503a-eng.php
In Hong Kong, there is no registered pharmaceutical product containing bamlanivimab. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 17 Apr 2021.
Ends/Thursday, Apr 29, 2021
Issued at HKT 15:00
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