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US regulators have allowed the emergency use of the experimental drug remdesivir, which appears to help some coronavirus patients recover more quickly.
It is the first drug to help fight Covid-19, which has killed more than 230,000 people worldwide.
Donald Trump announced the news Friday at the White House with Stephen Hahn, commissioner of the Food and Drug Administration (FDA), who said the drug would be available to hospitalized patients with Covid-19.
The president said the approval represented a “very promising situation” in the country’s fight against coronavirus, and Dr. Deborah Birx added: “I think this really illustrates what can happen in such a short time.”
The emergency approval comes days after Dr. Anthony Fauci, the government’s top infectious disease expert, expressed cautious optimism about the results of a remdesivir drug trial.
“The data shows that remdesivir has a clear, significant and positive effect on decreasing recovery time,” Fauci said earlier this week. “What it has shown is that a drug can block this virus.”
The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences’ remdesivir shortened recovery time by 31%, or about four days on average, for patients hospitalized with Covid-19.
The study of 1,063 patients is the largest and strictest test of the drug and included a comparison group that received standard care so that the effects of remdesivir could be rigorously evaluated.
Those who received the medication were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug may also be reducing deaths, although that is not certain from the partial results revealed so far.
Fauci said the drug would become a new standard of care for seriously ill Covid-19 patients like those in this study. The drug has not been tested in people with milder illnesses, and is currently administered intravenously in a hospital.
The FDA authorized the drug under its emergency powers to rapidly accelerate experimental drugs, tests, and other medical products to patients during public health crises.
In normal times, the FDA requires “substantial evidence” of the safety and effectiveness of a drug, usually through one or more rigorously controlled, large patient studies. But during public health emergencies, the agency can waive those standards, simply by demanding that the potential benefits of an experimental drug outweigh its risks.
There are no medications approved now to treat coronavirus, and remdesivir will still need formal approval. The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data on the safety and effectiveness of remdesivir.
The use of the medicine will be authorized for adults or children who are hospitalized with suspected or confirmed Covid-19 and whose condition is “severe”, which means they have low blood oxygen levels, need oxygen therapy or are on a ventilator. mechanic. the FDA said.
“Based on the evaluation of the emergency use authorization criteria and the available scientific evidence, it was determined that it is reasonable to believe that remdesivir can be effective in the treatment of Covid-19, and that since there are no adequate alternative treatments, Approved or available, the known and potential benefits of treating this serious or life-threatening virus currently outweigh the known and potential risks of using the drug, “the FDA said in its statement.
The Emergency Use Authorization (USA) also includes information on possible side effects, including “elevated levels of liver enzymes, which may be a sign of inflammation or damage to liver cells; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and chills. ”He also notes that there may be other serious side effects that have not yet been discovered.
The EUA requires hospitals to monitor patients’ liver enzymes through blood tests before starting treatment and every day that treatment is ongoing.
Patients receiving the medication will receive an information sheet, which is available here. The drug is administered intravenously once a day for up to 10 days.
Hahn said the approval of the drug for emergency use represented “a major clinical advance” in the fight against the coronavirus.
Daniel O’Day, the CEO of Gilead, said Friday that his company has already increased production of the drug and hopes to have millions of treatment courses available by the end of the year.
“I think it is important to note that this is a medication for the most severe patients,” O’Day told the Today program. “What we see here is, of course, not a cure, but a very, very significant and important treatment for patients.”
Agencies contributed reports
