The European drug authorities have approved the virus inhibitor remdesivir as the first drug against COVID-19 under certain conditions, the Medicines Evaluation Board (MEB) reports Thursday. The European Commission must take the advice before the medicine can be used in the European Union.
Remdesivir can be prescribed upon adoption of the advice to corona patients who are hospitalized with pneumonia and who need extra oxygen. There is already a temporary exemption in the Netherlands for the use of brake desivir.
Corona patients treated with remdesivir recover an average of four days earlier than other COVID-19 patients, the MEB reports. This is because this drug, originally an anti-Ebola virus, causes fewer new virus particles to be produced. The risk of death also appears to be smaller.
The authority reports that there is currently sufficient information on side effects and risks of use by corona patients. The most common side effects are an increased concentration of enzymes in the liver, headache, nausea and rash.
‘Positive effects of medicine outweigh risks’
However, the MEB points out that not all information from the studies into the effects of the drug is complete and known, but reports that there are “sufficient indications that the positive effects of the drug outweigh the risks”. Therefore, it was decided to approve the administration of the drug for one year under certain conditions.
Gilead Sciences is due to report new data to the European medicines authorities by December, which will then accelerate its assessment. This includes additional research results and information about the production process.
The current Dutch stock of the virus inhibitor had previously been donated by the manufacturer after discussions with Minister Hugo de Jonge (Public Health). He is still in talks with the company about making the remdesivir available to Dutch patients, he reported in a letter to parliament on Thursday.
According to the Ministry of Health, several patients in the Netherlands have so far been treated with the drug remdesivir, which came directly from Gilead Sciences. The exact number of patients involved is not known. In addition, one dose of the drug has so far been supplied to RIVM.
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