Corona: Approval of Remdesivir in EU applied for

Christine Albert studied German linguistics and literature as well as Scandinavian studies at the Albert Ludwigs University in Freiburg. She is currently doing a traineeship at Hubert Burda Media and is writing, among other things, for

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The US pharmaceutical company Gilead has officially applied for the limited approval of Remdesivir as an agent against Covid-19 on the European market. This was announced by the European Medicines Agency EMA on Monday in Amsterdam.

The examination of the submitted data and the weighing of effects and risks should be carried out according to a shortened procedure. A decision is expected "in a few weeks". It would be the first approval of a drug against Covid-19 in Europe.

Remdesivir is already in use in the USA

The authority had already started an accelerated approval process for remdesivir on April 30 and evaluated data from studies. The first cycle of this ended on May 15th. At the end of May, the EMA announced that a decision on approval was being delayed. First, the manufacturer had to officially submit the application.

At the beginning of May, the USA had already granted an exemption for the limited use of the active ingredient originally developed for the treatment of Ebola in hospitals. In Germany, the drug is available as part of a compassionate use program and is being tested in clinical studies.

Shorter duration of illness

An international study with over 1000 participants had shown that Remdesivir can reduce the time to recovery in Covid-19 patients by an average of four days. The mortality decreased slightly in the study, but this was not statistically significant.

Remdesivir has not yet been unrestrictedly approved as a drug in any country in the world. So far there is no vaccination against the coronavirus and no reliable approved drug therapy. (approx / dpa)

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