Remdesivir: Corona funds receive special approval in the US USA



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The United States can now use the crown drug Hope Remdesivir!

According to the FDA, the use of the drug in patients with Covid-19 in hospitals is limited. The exemption was given in light of the coronavirus pandemic “at the speed of light,” FDA chief Stephen Hahn (60) said Friday at the White House.

President Donald Trump (73) described the measure as “very promising”. A clinical study had previously shown that the drug originally developed for Ebola in patients with Covid can shorten recovery time by several days.

Gilead biotech company chief Daniel O’Day said the company would donate 1.5 million doses of remdesivir to US authorities, which should be enough for more than 100,000 treatments. Patients with Covid-19 lung disease could now receive the drug for five to ten days, depending on the severity of the condition.

The US government USA It will distribute the medication to ensure it gets where it’s needed most, he said. By December, they wanted to produce enough remdesivir for a million treatments.

Remdesivir has never been approved as a drug anywhere in the world. The United States exemption does not correspond to formal approval, which is a much more complex process. Even issuing a limited exemption after a promising clinical trial is unusual.

The head of Gilead O'Day (left), the President of the United States Trump (center) and the head of the FDA Hahn announced the approval of the drug Corona in the White HousePhoto: Alex Brandon / AP Photo / dpa

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Gilead O’Day chief (left), US President Trump (center) and FDA chief Hahn announced approval of the drug Corona at the White HousePhoto: Alex Brandon / AP Photo / dpa

So far, however, there has been no vaccination against coronavirus or approved and reliable drug therapy.

Remdesivir is said to have “significant positive effects”

On Wednesday, the US National Institute of Infectious Diseases. USA (NIAID) said that remdesivir had significantly shortened treatment time in a clinical trial. Director Anthony Fauci (79) spoke of a “significant positive effect in reducing recovery time.”

The study with more than 1000 participants was carried out with control groups, the data collection was accompanied by independent experts. According to Fauci, patients with Covid-19 coronavirus-related lung disease recovered after an average of 11 days, while patients in the control group only after 15 days.

The results had yet to be independently verified and published, Fauci said. Furthermore, the drug only resulted in a slightly lower mortality rate.

According to many experts, the results of the United States study appear to be reliable enough. Sufficient patients have been examined. Clemens Wendtner of the Munich Schwabing Clinic said earlier this week that she had been discharged from the hospital on remdesivir therapy: “This means that the study’s essential endpoints have been reached, so in my opinion There should be little doubt about the rapid approval of the substance. “

 Fauci believes in a Photo: Alex Brandon / AP Photo / dpa

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Fauci believes agent Corona has “significant positive effect”Photo: Alex Brandon / AP Photo / dpa

However: A Chinese study also featured this week in the journal “The Lancet” concluded that the condition of patients with remdesivir does not improve significantly. However, due to the lack of patients, this study was discontinued early.

The Chinese study included 237 patients from ten hospitals in Wuhan, the site of the pandemic. 158 received remdesivir, 79 an ineffective fake drug. The researchers found no statistically significant influence on disease duration or death rate. However, in addition to the early termination of the study, they point to another weakness: most of their patients were treated with remdesivir only late in the course of the disease.

Remdesivir had previously shown some efficacy against the Sars-CoV-2 coronavirus. In animal experiments, it worked against other coronavirus infections like Sars and Mers.

According to Johns Hopkins University, there are already around 1.1 million known infections with the new coronavirus in the United States. At least 64,000 people have died.



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