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May 01, 2020 – 04:57 p. m.
AFP / El País
The U.S. drug regulatory agency FDA has authorized the emergency use of the experimental drug remdesivir in patients with COVID-19, President Donald Trump announced Friday.
The use of this antiviral made by the American laboratory Gilead Sciences was approved after a major clinical trial showed that it shortens the recovery time in some patients with the new coronavirus. It was the first time that a drug showed a benefit against the disease.
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“It is really a very promising situation,” Trump said at the White House, alongside Gilead chief executive Daniel O’Day.
“We are honored with this first step for inpatients,” O’Day said, adding: “We want to make sure that nothing gets in the way of these patients receiving the medication.”
The company previously announced that it would donate around 1.5 million doses.
This equates to approximately 140,000 treatments, based on a duration of 10 days.
Remdesivir, which is given by injection, was already available to some patients who enrolled in, or received outside of, those trials in the so-called “compassionate use” modality.
The approval allows it to be distributed much more widely and to be used by both hospitalized adults and children who are seriously ill.
The Food and Drug Administration (FDA), which gave the green light to this emergency use, defines the state of gravity with low levels of oxygen in the blood, which makes it necessary to receive oxygen therapy or be connected to a respirator.
The United States National Institute of Allergy and Infectious Diseases (NIAID) revealed on Wednesday the encouraging results of a clinical trial involving more than 1,000 people.
He found that hospitalized COVID-19 patients with respiratory distress improved faster than those who received a placebo. Specifically, patients who took the drug had a 31% faster recovery time.
“Although the results were clearly positive from a statistically significant point of view, they were modest,” Anthony Fauci, a scientist who heads NIAID and one of Trump’s top advisers in this pandemic, said Thursday.
But while not considered a miracle cure, the remdesivir trial could pave the way for better treatments, according to Fauci.
Remdesivir is incorporated into the virus genome, causing a short circuit in its replication process.
It was first developed to treat Ebola, a viral hemorrhagic fever, but it did not increase survival rates like other medications.
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