FDA officially approves COVID-19 drug
On May 1, the US Food and Drug Administration (FDA) approved the emergency use of the experimental drug Remdesivira in the treatment of patients infected with coronavirus. Writes about this New York Post.
Research has shown that treatment with this antiviral drug can speed recovery in patients with COVID-19. US President Donald Trump made a joint statement with Dan O'Day, CEO of pharmaceutical company Gilead Sciences on the approval of the drug.
“I am delighted to announce that Gilead now has an FDA emergency clearance for Remdesivir. And you know what that means because it has been hot news in the media lately - this is an important treatment for hospitalized coronavirus patients, ”Trump said.
He added that he spoke with members of the White House Coronavirus Group, Dr. Anthony Fauci, Deborah Birks and FDA CEO Stephen Khan, and they all agreed that this was a “promising situation.”
“We've worked with teams at the FDA and the NIH (National Institutes of Health) and Gilead is now leading this public-private partnership to get things done really fast,” the president added.
“I think this really illustrates what can happen in such a short time. Less than 90 days have passed from the first case of coronavirus in the United States to today - our first step towards using a therapeutic agent to treat it, ”Birx said.
A federal study found that treatment with Remdesivir could speed recovery in patients with COVID-19. The FDA solution expands access to the drug by allowing any doctor to prescribe Remdesivir to their patients with COVID-19.
But this does not mean that the drug is recommended for all hospitalized patients. Clinical trials are still ongoing to determine which patients will benefit most from the Remdesivir treatment.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday, April 29, that there is positive news regarding this drug.
Emergency approvals are not the same as official agency approvals.
When the federal government announces a public health emergency, the FDA can approve medicines to deal with the emergency if there is no alternative.
According to Fauci, the data showed that Remdesivir had a positive effect on accelerating the recovery time of patients.
Trump and Fauci welcomed the first results of the study, on the same day when the death toll in the United States exceeded 60.
“This is very important because it has been proven that a drug can block this virus,” Fauci said. "It gives me hope."
The study involved 1 patients who were given Remdesivir or placebo. Recovery time averaged 063 days for those who received the drug, compared to 11 days for those who received a placebo.
However, the FDA warned in its newsletter that the drug is still experimental.
“There is no FDA approved drug for the treatment of COVID-19 yet. Taking Remdesivir may benefit certain hospitalized patients with COVID-19, ”the agency said in a statement.
The document also warns that people with certain diseases or conditions must inform them of their doctor before taking the drug. The list of these conditions includes allergies, problems with the kidneys or liver, pregnancy or breastfeeding, any serious diseases, taking other medications, vitamin or dietary supplements.
Adverse reactions to Remdesivir include lowering blood pressure, nausea, vomiting, sweating and tremors.
As ForumDaily wrote earlier:
- According to patient-based data, more than two-thirds of seriously ill patients with COVID-19 condition improved after treatment with Remdesivir.
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