This antiviral, already used in the United States, could become the first treatment authorized against Covid-19 in the European Union.
The evaluation of remdesivir has started, announced the European Medicines Agency (EMA) in a communicated, Monday, June 8. The organization has received a conditional marketing authorization request. The procedure will be accelerated and a decision should be made public in the coming weeks, if the data provided are sufficient.
A drug authorized in several countries
Remdesivir is a drug originally developed to fight the Ebola virus. This antiviral is an RNA polymerase inhibitor, that is to say it blocks the production of the virus’s genetic material, which prevents it from multiplying in the body.
In the United States, its use in the case of Covid-19 was authorized in May by the American Medicines Agency (FDA). “It is reasonable to believe that remdesivir may be effective against Covid-19 and that, given that there are no adequate, approved or available alternative treatments, the known and potential benefits for treating this severe and deadly virus are greater than the known and potential risks posed by the use of the drug”, the administration said at the time. Other countries also allow its use, including Japan, India and South Korea.
Conflicting trials
An American trial, conducted on more than 1,000 patients, showed that the Gilead laboratory treatment reduces the recovery time of patients with a severe form of the disease by 31%. Their survival was also more important. In another research, carried out in China, scientists conducted a trial on 237 patients, a much smaller sample: they found no improvement linked to the administration of remdesivir. A third study published in The New England Journal of Medicine confirmed the interest of the drug, it allowed patients to heal faster, when they were not placed on an artificial respirator.
Authorization from the High Council for Public Health
The drug is also part of the European Discovery study. The latter started in March and aims to analyze the effectiveness of 4 drugs in the treatment of Covid-19. His results could help clarify the effects of remdesivir.
In France, the High Council for Public Health said, in March, that it could be used in the most severe cases and taking into account “the very limited state of current knowledge”. It also specifies that the practitioner is liable insofar as the prescription is made in the absence of marketing authorization and outside of a clinical trial. The administrative decision must be taken collectively. The treatment was notably used in January for one of the first hospitalized patients with the new coronavirus.
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