FDA expected to quickly approve experimental coronavirus drug Remdesivir: U.S

05/03/2020 03:00 | 37

FDA expected to quickly approve experimental coronavirus drug Remdesivir: U.S

The experimental drug remdesivir has been authorized by United States regulators for emergency use against Covid-19, President Donald Trump announced Friday. A USA -led study released this week showed that patients who got the drug recovered in an average of 11 days, while those who get a placebo recovered in 15 days.

This comes days after early results from a study of the drug revealed it may help patients recover more quickly.

Dr. Anthony Fauci, NIAID director and the us government's top infectious disease expert, also sees promise in the results of the clinical trial.

Gilead said that ICU hospitals and hospitals that the federal government decides are most in need of the drug will have priority in receiving their limited supply of remdesivir.

FDA approves Gilead's Remdesivir drug for emergency use in Coronavirus patients.

A study out of the University of North Carolina - Chapel Hill showed that the drug reduces recovery time in coronavirus patients, The News and Observer reported.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery, " Fauci said. "Today's action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective", FDA Commissioner Dr. Stephen M. Hahn said.

Remdesivir, an antiviral drug used to treat hepatitis and a common respiratory virus, appeared to join thousands of other failed medications after being proven useless against these diseases.

"I don't think this is a cure yet, but I think it's starting to point us in the right direction", said Khanijo of North Shore University Hospital in NY.

A previous trial of remdesivir was stopped before completion, because China now lacks enough new patients for a useful sample and 12 percent of those participating suffered serious side-effects.

With emergency approval granted, Gilead can work with the government to directly ship the drug to hospitals with the greatest need, Mr. O'Day, told The Wall Street Journal earlier this week.

"We feel a tremendous responsibility - we're humbled by this being an important first step for hospitalized patients", Mr. O'Day said. This has brought the drug into focus as scientists across the world are searching for a better way to treat the disease and have raised several concerns about the effectiveness of the drug.

The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after Trump repeatedly promoted it as a possible treatment for Covid-19.

Emergency-use authorizations have a lower regulatory standard to meet than FDA approval, but it's a sign that the FDA believes it's headed in the right direction, according to CNN. Gilead's CEO Daniel O'Day said the company went from producing 5,000 courses of the drug per day to 100,000 and will have millions ready for use before the end of the year.

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