Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
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The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was based on a trial where the antibodies lowered risk of hospitalisation and death in COVID-19 patients.
In vitro neutralisation assays show REGEN-COV and AZD7442 are effective against the new SARS-CoV-2 variants, while other antibody therapies, including Eli Lilly’s bamlanivimab, were not.
Data from a Phase III trial shows high-risk patients treated with bamlanivimab and etesevimab were 70 percent less likely to be hospitalised due to COVID-19.
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.