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US FDA restricts use of monoclonal antibodies to treat Omicron cases

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Dr Veena Aggarwal, Consultant Womens’ Health, CMD and Editor-in-Chief, IJCP Group & Medtalks Trustee, Dr KK’s Heart Care Foundation of India    27 January 2022

Given their lack of neutralizing efficacy against the Omicron variant, the US FDA has restricted the use of bamlanivimab with etesevimab and casirivimab with imdevimab. These monoclonal antibody treatments are now authorized to be used “only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments”. 

The Omicron variant of SARS-CoV-2 has replaced the till now dominant delta variant in the United States and accounts for more than 99% of Covid-19 infections. More likely than not, this implies that these monoclonal antibodies can no longer be used to treat Covid-19 cases in the country, as per the US FDA.

The NIH COVID-19 Treatment Guidelines Panel has also recently recommended against their use because of reduced susceptibility of Omicron to these monoclonal antibodies.

Preliminary studies show that the only monoclonal antibody to display some activity against the Omicron variant is sotrovimab, which has been granted conditional recommendation earlier this month by the World Health Organization (WHO) for use in at-risk patients with mild or moderate Covid-19. This includes patients who are older, immunocompromised, with cormorbidities and those who are unvaccinated.

(Source: US FDA, Jan. 24, 2022 & WHO News Jan. 14, 2022)

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