The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has completed its review on the use of the monoclonal antibodies casirivimab and indevimab to treat patients with covid and has concluded that the combination of these compounds, also known as REGN-COV2, can be used to treat the disease in patients who do not require supplemental oxygen, but are at high risk of severe progression of the infection.
The monoclonal antibody treatment was the one received by former US President Donald Trump during his illness.
The EMA's decision comes after reviewing data from a trial on the effects of using casirivimab and indevimab in outpatients with covid who did not need supplemental oxygen.
"Preliminary results indicate that the combination reduced the viral load (amount of virus in the back of the nose and throat) and led to fewer medical visits related to the disease," concludes the EMA.
In terms of safety, most of the reported side effects were mild or moderate.
However, monitoring of administration-related reactions is recommended.
The final resolution that will allow the commercialization of the drug will be made when a review that began on February 1 and is still open is completed.
REGN-COV2, the treatment that Donald Trump received after becoming infected last November, is based on monoclonal antibodies, a type of protein designed to recognize and adhere to the SARS-CoV-2 spike at two different sites and avoid entry of the virus into the cells of the body.
Monoclonal antibodies locate and eliminate the specific molecule that the coronavirus uses to bind to human cells and use them in its mass replication strategy
These antibodies locate and eliminate the specific molecule that the coronavirus uses to bind to human cells and use them in its massive replication strategy.
This molecule is known as the Receptor Binding Domain (RBD).
If an antibody binds to them before the virus enters cells, it blocks infection.
The Regeneron company has tested the effectiveness of its antibody cocktail both in preventing infections and in treating infected patients.
In one of the trials, it found that antibodies reduce viral load by up to 99% and make convalescence last seven days instead of 13. In previous work, the company showed that the cocktail reduces viral load and even prevents convalescence. infection in macaques and hamsters.
The average price of these compounds in the US is about $ 100,000 (about 85,000 euros), according to a 2018 study. In July, Regeneron received 450 million dollars from the US Government within the Warp Speed operation to supply about 300,000 Antibody doses before the end of the year in case their efficacy is proven.