Thursday June 25, 2020
–
The first drug against Covid-19 could soon be launched on the European market. But although it is said to help the seriously ill, Remdesivir is controversial. Here are the answers to the important questions about the Ebola drug.
The European Medicines Agency Ema is paving the way for that first drug against Covid-19 released in the European Union (EU). But Remdesivir – trade name Veklury – is quite controversial. The agency in Amsterdam initially only recommended conditional approval. The necessary approval by the European Commission, which Ema says will decide next week, is a matter of form. Here are the answers to the most important questions about the product.
What is Remdesivir?
Remdesivir was originally developed to treat the Ebola virus, but was never approved for this use. There were later indications that the drug could work against coronaviruses.
How does the remedy work?
Remdesivir is administered by infusion and inhibits an enzyme in the virus that is essential for its multiplication.
How is the study situation?
Several studies on remdesivir have been published, but many are unlikely to be effective. However, in late April, Anthony Fauci, head of the United States National Institute for Infectious Diseases, announced positive results from an international study. At the end of May they were published in the “New England Journal of Medicine” (“NEJM”). About half of the 1063 subjects received Remdesivir. The others came into the control group. Gerd Fätkenheuer, Head of Infectiology at Cologne University Hospital, was involved.
What success has Remdesivir had?
“We have shown that the drug alleviates the severe course of a Covid 19 disease and shortens the disease phase by about four days,” said Fätkenheuer. The patients with remdesivir had a recovery time of eleven days, that of the control group of 15. Fauci spoke of a “significant positive effect in reducing the time to recovery”. Remdesivir is generally very well tolerated, said Fätkenheuer. The study had even more side effects in the control group than in patients with remdesivir. In both groups, however, people died of the corona virus. The authors write in the “New England Journal of Medicine” that the administration of antiviral agents alone is probably not sufficient for therapy.
Are there any criticisms of the approval?
Yes. The most well-known critic in Germany is Uwe Janssens, President of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI). He stressed that there was no published evidence that remdesivir reduced mortality. “There is no evidence that we save lives here.” Janssens warns: “As scientists, we have to remain sober. We cannot hang cherries in the tree and give the public a hasty feeling that we have found a drug that can treat the disease successfully.”
Successful treatment means, among other things, a substantial reduction in mortality. And that is not the case at the current state. “There are definitely no valid and reliable long-term results for Covid-19 patients,” emphasizes Janssens. “And in principle, in intensive care medicine, we would like such study results to be confirmed by another study.”
Fätkenheuer rejects the criticism: “If you read ‘Four days less sick’, you might say: Well, what the hell? Does that matter so much? But of course it makes a huge difference whether someone comes to the intensive care unit and has artificial respiration or whether he is spared that. And that may depend on this medication, we have had cases like this in the study. ” In addition, there was a difference in mortality, “but not statistically significant”.
Are there any economic interests associated with the preparation?
Yes, very big. Remdesivir is produced by the US pharmaceutical company Gilead Sciences. “I think it’s a political issue,” says Janssens. “The pictures from the White House, where the head of Gilead Sciences is standing next to Trump, who says that these are ‘incredible results’, are significant. It’s about a lot of money. Tangible economic interests play an important role, entangled with probably need for success from politics. That we can defeat the disease. “
Who should be treated with Remdesivir?
Fätkenheuer reports that the drug was tested in the study in both mild and seriously ill patients. The study showed that especially patients in the early stages of the disease benefited from remdesivir.
When will the drug be available in Germany?
According to the Federal Ministry of Health, remdesivir is available to affected patients in Germany immediately after entering the market and is therefore reimbursed by the health insurance companies. Do you have to fear that Gilead will only supply the US market and Europe will have to wait until next year? “I think that is extremely unlikely,” says Fätkenheuer. After all, the company is very active on the European pharmaceutical market.
– .
