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COVID-19: Remdesivir approved as the first corona drug

COVID-19: Remdesivir approved as the first corona drug



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Remdesivir: saving medicine or business model?

Around eleven million infections with the SARS-CoV-2 coronavirus are now known worldwide. Over half a million deaths are associated with COVID-19 disease. International research teams are still desperately looking for treatment strategies. The first drug for the treatment of COVID-19 has now been approved in Europe. It is the Ebola drug Remdesivir.

A drug against COVID-19 is approved for the first time in the EU. It could help seriously ill patients. At the moment, however, the USA has secured a large part of its production.

Controversial drug approved for COVID-19 treatment

The EU Commission has approved the drug Remdesivir for the lung disease COVID-19. The states are thus following the European Medicines Agency (EMA), which recommended conditional approval on June 25. But Remdesivir - trade name Veklury - is quite controversial.

What is Remdesivir?

The drug from the US pharmaceutical company Gilead Sciences was originally developed for the treatment of the Ebola virus disease, but was never approved for this use. There were later indications that it could work against coronaviruses. Remdesivir is administered by infusion and inhibits an enzyme of the virus that is necessary for its multiplication.

How is the study situation?

Several studies on remdesivir have been published, but many are unlikely to be effective. In May, however, an international team presented the first positive results in the "New England Journal of Medicine" (NEJM). Around half of the 1063 test subjects received Remdesivir. The other participants were the control group.

What success has Remdesivir had?

"We have demonstrated that the drug alleviates the severe course of a COVID-19 disease and shortens the disease phase by about four days," says the infectiologist Gerd Fätkenheuer from the University Clinic Cologne of the German Press Agency. The participants with remdesivir had a recovery time of 11 days, that of the control group of 15.

Remdesivir is generally very well tolerated, says Fätkenheuer. The study had even more side effects in the control group than in the remdesivir group. In both groups, however, people died of the corona virus. The authors write in the NEJM that the administration of antiviral agents alone is probably not sufficient for therapy.

Criticism of the admission

The most notable 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 to date that remdesivir reduced mortality. "There is no evidence that we save lives here." For him, successful treatment also means 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, you were four days less sick," you might say: well, what's the matter? Does that matter so much? But of course it makes a world of difference whether someone comes to the intensive care unit and is artificially ventilated, or whether he is spared that. And that can depend on this drug, we have had cases like this in the study. ”

Who should be treated with Remdesivir?

Fätkenheuer reports that the drug was tested in the study for both mild symptoms and seriously ill patients. The study had shown that especially those affected early in the disease benefited from remdesivir.

Will the drug be available in Germany?

The United States has secured a large part of the Remdesivir production volume targeted until September. According to the Ministry of Health, Germany secured remdesivir supplies early on. There are still enough reserves at the moment. After the approval, he expects from the US manufacturer "that Germany and Europe will be supplied when it comes to such a drug," said health minister Jens Spahn (CDU) on Thursday (July 2) in the "ZDF morning magazine".

Where is Remdesivir made?

Remdesivir's main manufacturing site is La Verne, California. "However, we have added significant additional capacities from several production partners in North America, Europe and Asia to our own production," said Gilead spokesman Martin Flörkemeier in Germany. Gilead also has licensing agreements with nine generic companies in Egypt, India and Pakistan. Production had already increased significantly, but it could not be ramped up quickly in the event of a major outbreak.

What does the drug cost?

A five-day treatment with remdesivir, according to the company, will cost $ 2,340 per patient if the US government orders it. This net amount is also planned for Germany, said Flörkemeier. In Germany, the costs are paid by the health insurance companies. The researcher Fätkenheuer criticized the price as "enormously high". "I would expect that social and ethical considerations play a role in a drug like Remdesivir," said the infectiologist to the "Kölner Stadt-Anzeiger". (vb; source: Christoph Driessen, dpa)

Author and source information

This text corresponds to the requirements of the medical literature, medical guidelines and current studies and has been checked by medical doctors.

Graduate editor (FH) Volker Blasek

Swell:

  • EMA: Summary on compassionate use Remdesivir Gilead (as of April 3, 2020), ema.europa.eu
  • John H. Beigel, Kay M. Tomashek, Lori E. Dodd, et al .: Remdesivir for the Treatment of Covid-19 - Preliminary Report; in: New England Journal of Medicine, 2020, nejm.org


Video: Coronavirus: US Buys nearly all of Covid-19 drug remdesivir - BBC News (August 2022).