Remdesivir receives EU approval: How well the Corona-hope really is?

Remdesivir receives EU approval: How well the Corona-hope really is?

For the first time the EU has admitted Commission of a drug against a lung disease Covid-19. The States are following the European medicines Agency EMA, the on 25. June had recommended approval, subject to conditions. But Remdesivir – trade name Veklury – is quite controversial.

What is Remdesivir?

The Mediterranean, the US pharmaceutical company Gilead Sciences was originally developed for the treatment of Ebola virus disease, but never for this use approved. Later, there were indications that it might act against corona viruses. Remdesivir is administered by Infusion and inhibits an enzyme the virus for their propagation is necessary.

How is the study location?

There are several studies have been published to Remdesivir, but many were hardly any conclusions on efficacy. In may, an international Team presented the first positive results in the "The New England Journal of Medicine" ("NEJM"). About half of the 1063 subjects got Remdesivir. The other came in the control group.

What success has the Remdesivir?

"We have demonstrated that the drug is a Covid-19-disease, and softens the severe progression of the disease phase of about four days verkürzt", the study involved infections Loge, Gerd Fätkenheuer of the University hospital of Cologne, the German press Agency said. The patients with Remdesivir had a recovery time of 11 days, the control group of 15. Remdesivir was overall very well tolerated, says Fätkenheuer. The study reported in the control group even more side effects than in patients with Remdesivir. In both groups, people died, however, on the Coronavirus. The authors write in the "NEJM", the administration of antiviral agents alone was not sufficient, probably, to the therapy.

Read more about Coronavirus in the News-Ticker of FOCUS Online.

There is criticism of a marketing authorisation?

Yes. The most notable critics in Germany, Uwe Janssens, President of the German Interdisciplinary Association for Intensive and emergency medicine (DIVI) is. He stressed that so far there is no published evidence that Remdesivir lowering the mortality rate. "There is no evidence that we save lives here." Successful treatment mean for him, among other things, substantial reduction in Mortality. And not to be given according to the current state. "It is valid and reliable long-term results for Covid-19-Patienten&quot missing definitely;, stressed Janssens also. "And in principle we would wish in intensive care medicine, such study results are confirmed by further study."

Fätkenheuer &quot rejects the criticism:;If you read 'four days less sick gewesen', you might say: Well, what soll's? Makes this so much? But it is a sky is of course a difference whether someone is on the intensive and artificially ventilated, or whether he will be spared. And that can depend on this drug, such cases, we have had in the study."

Who should be treated with Remdesivir?

The agent had been tested in the study, both in the case of slight as in the case of seriously ill patients, reports Fätkenheuer. The study showed that especially patients benefited at an early stage of the disease of Remdesivir.

Will be the funds available in Germany?

The USA have secured the majority of the to September is the targeted production amount of Remdesivir. Germany has secured, according to the Ministry of health at an early stage Remdesivir supplies. There is currently enough reserves. He added that he expects the US manufacturer to the marketing authorisation, "that Germany and Europe are supplied, if there is such a drug geht", the Minister of health, Jens Spahn (CDU) said on Thursday in the ZDF-"Morgenmagazin".

The main production site of Remdesivir La Verne in California. "However, we have ergänzt&quot our own manufacturing due to significant additional capacity of several production partners in North America, Europe and Asia;, the speaker of Gilead, in Germany, Martin flörke Meier explained. Gilead have also completed license agreements with nine generic drugs manufacturers in Egypt, India and Pakistan. It had increased the production significantly, it could not be driven in the case of a large outbreak of rapidly more high.

What the drug costs?

A five-day treatment with Remdesivir will cost according to the company, at the time of order by the US government, 2340 dollars (about 2000 Euro) per Patient. This net amount is also planned for Germany, insured flörke Meier. The costs are paid for in Germany by the funds. The researchers Fätkenheuer criticized the price as "enormous hoch". "I would expect that societal and ethical aspects in the case of a drug like Remdesivir a role spielen", the infection Loge said the "Cologne City Of-Anzeiger".

Summer Outlook: June begins wet but then the change comes

The Weather Channel summer Outlook: July starts wet, but then comes the reversal

CSU woman’s decomposed AfD-request – then pulls out suddenly, a handkerchief

FOCUS Online/Wochit “For your crocodile tears”: CSU-woman decomposed AfD-request – then pulls out of you suddenly, a handkerchief