For the treatment of severe Coronavirus infections the European medicines Agency EMA has expanded its recommendations for limited use of the active substance Remdesivir.
It could now be additionally applied in the case of certain hospitalised patients, which are not dependent on ventilators, said the EMA.
Unclear Side Effects
A clinical study from the United States had pointed out that the administration at Covid-could shorten a patient’s time to recovery by several days. The first results showed that the drug led rate, however, only to a slightly lower mortality.
Also secured information on side effects, and which patients might benefit most from treatment are missing.
The EMA values this data is currently in the context of the ongoing examination of Remedesivir from, it said. Used the product can be according to the EMA-recommendation is now about even with non-invasive ventilation, or if the seriously ill Patient is supplied with additional oxygen.
Drug against Ebola
Remdesivir was originally developed for the treatment of Ebola and is not yet approved in any country of the world as a drug. It is considered to be a possible means for the treatment of hard-to-corona virus infections. The United States issued in early may, a derogation for the limited use of the drug in hospitals.
In Germany, the Mediterranean, within a compassionate use program is accessible and is being tested in clinical trials.
Against the Coronavirus Sars-CoV-2 there is not, as yet, no preventive vaccine, even in a reliably acting approved drug therapy for the Virus-caused disease Covid-19 there are up to now.
Authority shall decide further course of action
In the EU, 30 was on. April the editing of a special authorisation procedure for Remdesivir started. In this so-called “rolling submission”, an applicant shall submit data from the studies and laboratory tests, one after the other.
You will then be assessed by the European medicines Agency, or more precisely, the for medicinal products for human use to the competent body of the CHMP. If the data are complete, the applicant may make a request for approval. So the approval process should be accelerated. Is made Remdesivir from the Biotech company, Gilead.
Deutsche Presse-Agentur (dpa)
*The article “Coronavirus: drug against Ebola infection duration published will shorten” by FitForFun. Contact with the executives here.