EMA starts rolling review of new medicines for treatment of COVID-19
The European Medicines Agency, EMA, has started a rolling review of a number of medicines for the treatment of COVID-19. No conclusions about the medicines have been drawn yet.
The rolling review is based on the results from two studies, one from the pharmaceutical company Eli Lilly looking at the ability of bamlanivimab and etesevimab to treat COVID-19 when used combined, the other looking at the efficacy of bamlanivimab when used alone. The EMA is presently evaluating the preliminary data which come from animal studies, and it is therefore too early to draw any conclusions regarding the efficacy and safety of the medicines as data from subsequent trials are to follow.
The EMA will evaluate all data on these medicines, including evidence from the clinical trials as they become available. The rolling review will continue until enough evidence is available to support formal marketing authorisation applications.
The EMA will assess the medicine’s compliance with the usual standards for effectiveness, safety and quality. It is uncertain when the final assessment will be made, but the process is expected to be quicker than a regular evaluation because data will be evaluated as soon as they become available.
How are the medicines expected to work?
Bamlanivimab and etesemivab are two so-called monoclonal antibodies with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure – an antigen. Bamlanivimab and etesevimab have been designed to attach to the spike protein at two different sites. The spike protein is found on the surface of the virus (SARS-CoV-2) causing COVID-19. When the antigen attaches to the spike protein, the virus’ ability to enter the body’s cells is impaired. Because the antibodies attach to different parts of the protein, using them in combination may have a greater effect than using either alone.