May 10, 2021

FDA Revokes Emergency Use Authorization for Bamlanivimab for COVID-19

The FDA has revoked the emergency use authorization (EUA) that allowed for bamlanivimab – an investigational monoclonal antibody – for the treatment of mild-to-moderate COVID-19.

This change reflects the use of bamlanivimab when administered alone. Bamlanivimab is still authorized for use when combined with other monoclonal antibodies, such as etesevimab.

In November of 2020, the FDA granted bamlanivimab an EUA because clinical evidence at the time found that bamlanivimab alone could benefit patients with mild-to-moderate COVID-19. However, based on ongoing analysis of emerging scientific data, there has been a sustained increase of COVID-19 viral mutations that are resistant to bamlanivimab when administered alone.

At this time, there are currently no testing technologies available that enable healthcare providers to test individual patients for COVID-19 viral variants prior to the start of treatment with monoclonal antibodies. Monoclonal antibody treatment should utilize drugs that are more broadly expected to work across all viral variants, and for these reasons the EUA for bamlanivimab has been revoked.

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