Italian Medicines Agency Agenzia Italiana del Farmaco

EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) - EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)

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EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibodies bamlanivimab and etesevimab to treat patients with COVID-19.

This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation.

The Agency concluded that bamlanivimab and etesevimab can be used together to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of their COVID-19 disease becoming severe.

The Agency also looked at the use of bamlanivimab alone and concluded that, despite uncertainties around the benefits of monotherapy, it can be considered a treatment option.


Published on: 05 March 2021

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