Other safety alerts
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| European Union: EMA issues advice on use of antibody combination (bamlanivimab ／ etesevimab) |
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European Medicines Agency (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.
EMA made its recommendations following a review of data including quality data, and data from a study that looked into the effects of monotherapy and combination therapy in outpatients with COVID-19 who do not need supplemental oxygen. Although some uncertainties remain, particularly around the benefits of monotherapy, the results indicate that the combination reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment). The results also indicated that the combination and monotherapy led to fewer COVID-19-related medical visits.
In terms of safety, most side effects reported were mild or moderate; however, reactions related to the infusion (including allergic reactions) are likely and should be monitored for.
EMA’s recommendations can now be used to support national advice on the possible use of the antibodies before a marketing authorisation is issued.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-issues-advice-use-antibody-combination-bamlanivimab-etesevimab
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, 6 Mar, 2021
Issued at HKT 13:00
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