The European Medicines Agency (EMA) this Thursday began a continuous review, a real-time analysis of the data that become available, of the treatment of covid-19 with monoclonal antibodies developed by the American pharmaceutical Eli Lilly.
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The European regulator, based in Amsterdam, will study all the information that the laboratory is sharing on the antibodies bamlanivimab and etesemivab, used as a combination for the treatment of COVID-19 in infected people, although this review will also analyze the use of bamlanivimab alone to treat this disease.
This step, which could lead to an official license for use in the European Union (EU), is justified in the preliminary results of two studies: one that analyzes the ability of drugs to treat the disease caused by SARS-CoV-2 when used as a combination of both antibodies, and another when bamlanivimab is used alone.
“However, the EMA has not yet evaluated the complete data set and it is too early to draw conclusions about the benefit-risk balance of the drugs,” the agency said in a statement.
The first batch of data that the EMA is currently analyzing is the result of animal studies, that is, non-clinical data, and will evaluate all data, including evidence from clinical trials in volunteers, as they become available. as part of the ongoing evaluation, which will continue until there is enough information to support the formal application for a community license.
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At the moment and given the phase in which this analysis is in, the EMA does not have a general review schedule with fixed dates, although the continuous review allows to carry out analysis work to expedite the study of a possible license in the future, when it is have verified that the Eli Lilly treatment meets the usual standards of efficacy, safety and quality.
At the end of January, Hungary became the first EU country to receive a consignment of 2,400 units of the drug bamlanivimab to treat covid-19 patients, said the head of the Hungarian health service, Cecília Müller, about a drug that reduces the risk of symptomatic infection is 75% and can be applied between 7 and 10 days after infection.
Along with Lilly’s treatment, the EMA is analyzing in real time the monoclonal antibody regdanvimab (CT-P59), developed by Celltrion, in addition to the combination of REGN-COV2 antibodies (casirivimab / imdevimab), from the pharmaceutical company Regeneron-Roche, which rose to fame when it was used as an experimental cocktail to treat former President Donald Trump when he caught SARS-CoV-2 last year.
The EMA Committee for Human Medicines (CHMP) has already provided a positive scientific opinion on the possible use of the combination of monoclonal antibodies bamlanivimab and etesevimab, and casirivimab and imdevimab, with the aim of giving a harmonized vision at European level on their use at the national level in each country until the continuous reviews requested by the laboratories are completed and a European license is issued.