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Europe also authorizes remdesivir, the first approved treatment for coronavirus

2020-07-03T19:20:01.508Z


This experimental therapy, which had already been endorsed by the United States, will be applied to adults and children with pneumonia. Europe is now negotiating the purchase of doses, which are worth $ 390 each.


07/03/2020 - 11:23

  • Clarín.com
  • Society

This week, the United States Government announced the purchase of half a million doses of remdesivir. And now, this drug that appears as one of the great therapeutic promises to curb the coronavirus, had a new boost: the European Commission (EC) authorized its use in Europe on Friday , after the European Medicines Agency (EMA) I would recommend last week.

The Community Executive, which granted the guarantee in an accelerated process, indicated in a statement that it granted "a conditional marketing authorization" for remdesivir, which thus becomes " the first authorized medicine at the European Union level for the covid-19 treatment . ”Adults and adolescents over 12 years with pneumonia will be prescribed.

Remdesivir is an experimental therapy that started developing in 2009 and was tested with Ebola patients in the middle of the last decade. An American clinical trial showed that it shortens the recovery time in some patients with the coronavirus. The antiviral slows down the production of new virus particles, and as a result, such an infection develops less quickly, and critically ill patients recover an average of four days earlier than usual.

Remdesivir, the drug approved in Europe. (EFE)

Brussels explained that data on remdesivir was analyzed "in an exceptionally short period of time through a continuous review procedure", given the public health emergency of the coronavirus.

"This has allowed the authorization to be granted quickly in the context of the coronavirus crisis, within a week after the EMA recommendation, compared to the usual 67 days," the EC noted.

"Conditional" authorization to sell a drug means that it can be marketed with slightly less data available and before the usual time it takes for a drug to be licensed under normal conditions, facilitating rapid access to the product in contexts such as a pandemic .

"Today's authorization of a first medicine to treat covid-19 is an important step forward in the fight against this virus," said European Commissioner for Health Stella Kyriakides, adding that Brussels "will not leave a stone unturned in its efforts to guarantee efficient treatments or vaccines against coronavirus ”.

Europe is already negotiating with the US pharmaceutical company Gilead Sciences to reserve enough doses of the drug, after the United States has secured the purchase of more than 500,000 treatments for the country's hospitals until September. Specifically, the volume already acquired represents 100% of the production for July, and 90% for August and September.

In the United States, since the use of remdesivir for coronavirus sufferers was approved in May, hospitals have used doses donated by Gilead, which will start charging for the drug from July. On Monday, the US pharmacist set the price of the drug at $ 390 a vial for governments in developed countries, which would raise the price of the most common treatment to $ 2,340 per patient and that of the longest therapies to $ 4,290. In the case of developing countries, Gilead indicated that it reached several agreements with producers of generic drugs to be able to offer the treatment at a lower price and facilitate its access worldwide.

Source: Agencies

Source: clarin

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