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The European Commission provisionally authorized this Friday the sale of the antiviral drug remdesivir for the treatment of patients with coronavirus in the European Union (EU), after the approval of the European Medicines Agency.

The community executive granted "a conditional marketing authorization for the medicine remdesivir, making it the first medicine authorized at the EU level for the treatment of COVID-19," it announced in a statement.

Brussels highlighted that this permit has been obtained in an "exceptionally short" period, thanks to an accelerated procedure that has also received the approval of the Member States and which has made it possible to shorten the time compared to the 67 days on average that it usually takes to grant these authorizations, reports Europa Press.

Conditional authorizations are granted to those drugs in which the benefits derived from their use outweigh the risk derived from the fact that there is less data than is normally required for full authorizations, according to the EMA on its website.

Commissioner for Health and Food Safety Stella Kyriakides stressed that this preliminary authorization granted by remdesivir is "an important step forward in the fight against the virus . " She also assured that the fact that it was granted "less than a month after the request clearly shows the determination of the EU to respond quickly when new drugs are available."

"We will spare no effort to ensure efficient treatments or a coronavirus vaccine," the Cypriot commissioner said in a statement.

The announcement also comes a day after the community executive confirmed that it is negotiating with Gilead Sciences the reservation of vials of this antiviral, a movement that has become known after the United States announced an agreement with the pharmaceutical company to ensure supply. of this drug until September.

"The Commission is also currently in negotiations with Gilead about the possibility of reserving doses of remdesivir for the Member States," Health spokesman for the Community Executive, Stefan De Keersmaecker, said at a press conference on Thursday.

Following the announcement that the United States had purchased all stocks of the antiviral remdesivir, one of the drugs that, in preliminary trials, has shown some activity against Covid-19, concern has grown over the availability of the drug globally .

This Thursday, Health assured that there is a sufficient stock of the drug in Spain both to face the current epidemiological situation and to face possible outbreaks of coronavirus.

In addition, he recalled that the drug is only recommended in adults and adolescents over 12 years of age with pneumonia who require oxygen.

On the other hand, sources from Gilead, the pharmaceutical company that develops the drug, told this newspaper yesterday that they are "working as fast as possible to allow access worldwide" to the drug and has advanced that "to further expand access and supply "have reached" non-exclusive voluntary license agreements with 9 generic manufacturers to manufacture and distribute generic versions of remdesivir in 127 developing countries.

The first 1 40,000 doses manufactured , supplied to clinical trials worldwide , have already been exhausted . The US has purchased more than 500,000 doses, representing 100% of Gilead's projected production for July (94,200 treatments), 90% of production in August (174,900), and 90% of production in September (232,800), plus an allocation for clinical trials. A remdesivir treatment uses, on average, 6.25 vials.

At the moment, the medicine is available through the AEMPS procedure for Medicines in Special Situations , which is used to facilitate access to investigational treatments when there are no other therapeutic alternatives.

Several experts have criticized the excessive price of the drug (set at 347 euros a dose, when it is usual for each patient to need six), despite the fact that its efficacy is still under investigation. There is no evidence of its effect in reducing mortality associated with the disease, they recall.

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