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US FDA allows emergency use of experimental drug Remdesivir for coronavirus

FDA says drug, which appears to help some recover faster, would be available for hospitalized Covid-19 patients

US regulators have allowed the emergency use of the experimental drug remdesivir, which appears to help some coronavirus patients recover faster.
It is the first drug shown to help fight Covid-19, which has killed more than 230,000 people worldwide.
Donald Trump announced the news on Friday at the White House alongside Stephen Hahn, the Food and Drug Administration (FDA) commissioner, who said the drug would be available for patients hospitalized 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-cut, significant, positive effect in diminishing the time to recovery,” Fauci said earlier this week. “What it has proven is that a drug can block this virus.”
The FDA acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized Covid-19 patients.
The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could be rigorously evaluated.
Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
Fauci said the drug would become a new standard of care for severely ill Covid-19 patients like those in this study. The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.

The FDA authorized the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.

In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards, simply requiring that an experimental drug’s potential benefits outweigh its risks.
No drugs are approved now for treating the 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 of remdesivir’s safety and effectiveness.
Use of the drug will be authorized for adults or children who are hospitalized with suspected or confirmed Covid-19 and whose condition is “severe”, meaning they have low blood oxygen levels, need oxygen therapy or are on a mechanical ventilator, the FDA said.

“Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating Covid-19, and that, given there are no adequate, approved or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the FDA said in its statement.
The emergency use authorization (EUA) also includes information about possible side effects, which include “increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating and shivering”. It also notes that there may be other serious side effects that have not been discovered yet.

The EUA requires hospitals to monitor patients’ liver enzymes through blood tests before the treatment is started and every day that treatment is ongoing.

Patients who receive the drug will be provided with a fact sheet, which is available here. The drug is administered through an IV once a day for up to 10 days.
Hahn said the drug’s approval for emergency use represented “an important clinical advance” in the fight against coronavirus.
Daniel O’Day, the Gilead CEO, said Friday that his company has already ramped up production of the drug and hopes to make millions of treatment courses available by the end of the year.
“I think it’s important to note that this is a medicine for the most severe patients,” O’Day told the Today show. “What we see here is really, of course, not a cure but a very, very significant and important treatment for patients.”


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