The active ingredient Remdesivir could come soon in Europe as well as the first remedy against a heavy Corona disease on the market.
The European medicines Agency EMA has recommended in Amsterdam, a registration subject to conditions for the agent with the trade name Veklury.
The EU Commission has to agree to that yet, but as a matter of form. The decision of the Commission should, according to the EMA in the coming week.
The recommendation from the EMA for the treatment of adults and adolescents from 12 years of age. The prerequisite for treatment is that the Patient has a pneumonia, and supplemental oxygen must be supplied.
An international study with over 1000 participants has shown at the end of April, that Remdesivir at Covid-19-patients can shorten the time to recovery in an average of four days – from 15 to 11 days.
The mortality has not decreased in the study slightly, which was statistically significant.
The US had already been issued at the beginning of may a derogation for the limited use of the drug in hospitals.
In Germany, too, the Mediterranean was already within a compassionate use program is accessible and is being tested in clinical trials.
Remdesivir was originally developed for the treatment of Ebola, but showed a low effect. It is not yet approved in any country in the world fully as a drug.
So far there is no vaccine against the novel Coronavirus, and also no reliable approved drug therapy.
The for medicines in the EU, the competent authority had, on 30. April started in the face of a medical emergency, a fast-track procedure for the admission of Remdesivir.
The applicant shall provide data from studies and laboratory tests, one after the other. These are then evaluated in a timely manner.
Once the data is complete, the application for approval. Remdesivir is made by the U.S. Biotech company Gilead Sciences.
The official application for the limited admission of Remdesivir on the European market, Gilead had made at the beginning of June.
The EMA had already recommended at the beginning of April the use of Remdesivir for the seriously ill without treatment alternative (“Compassionate use”).
In Germany, the Federal Institute for drugs and medical devices (BfArM) has confirmed in April the so-called compassionate use program for Remdesivir.
This has already been part of Doctors in this country, individual patients had no alternative treatment for the active ingredient to be administered allowed.
Deutsche Presse-Agentur (dpa)
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