COVID-19 Drug: Trump Administration Pushes Use of Remdisivir, EU Regulators Start Safety Review

By Madelaine D. First Posted: Oct 05, 2020 06:17 AM EDT

Remdesivir has gone through many clinical trials in Chicago. President Donald Trump was given Remdesivir to recover from COVID-19, according to CBS Chicago.

A doctor told CBS 2's Steven Graves on Saturday that the drug might be a game-changer in Trump's recovery.

A part of one of the biggest studies on remdesivir in the country, with positive results, Dr. Kathleen Mullane said the president would benefit from the drug.

However, the European Medicine Agency is now conducting a safety review on Remdesivir, following reports that several patients have developed severe kidney problems after they took the drug.

COVID-19 Drug: Trump Administration Approves Remdisivir, EU Regulators Start Safety Review

(Photo : Doug Mills)
President Trump Meets With Louisiana Governor John Bel Edwards At White House WASHINGTON, DC - APRIL 29: Dr. Anthony Fauci (2nd L), Director of the National Institute of Allergy and Infectious Diseases, discusses early results of testing the drug Remdesivir during a meeting with U.S. President Donald Trump and Louisiana Gov. John Bel Edwards (2nd R) in the Oval Office of the White House April 29, 2020 in Washington, DC. Fauci said the early testing results were "quite good news".

Health authorities are planning to halt the usage of remdesivir in certain countries until more safety studies are done after receiving reports that some patients taking the Remdesivir reported serious kidney problems.

Initially, the drug was granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) under the Trump administration despite doubtful results. Remdesivir also has no proven direct efficacy studies that it inhibits SARS-COV-2, as per Thailand Medical.

Remdesivir was only approved only because it shortens hospitalization stays of the patients. But it does not decrease mortality rates, nor any long term safety studies were done on it.

In the U.S., the treatment for COVID-19 disease using Remdesivir costs over $3,600 for the five-day course and starts over $7,200 for the generic versions in India.

On Saturday, a White House staff said that Trump got the second dose of Remdesivir.

In the President's latest video on Saturday, Trump said he was grateful for the support and the treatments he gets. "If you look at the therapeutics I'm taking right now, some of them, and others that are coming out right now that are looking like, frankly, they're miracles," said the President.

pic.twitter.com/gvIPuYtTZG — Donald J. Trump (@realDonaldTrump) October 3, 2020

Remdisivir is one of those drugs that aim to stop the coronavirus from spreading. It also targets to give a patient's immune system a chance to fight it off. Most benefits saw by higher-risk patients like Trump.

Mullane said: "He [Trump] fits the criteria for the early criteria for the emergency use of the drug." Mullane held two studies about remdesivir and COVID-19, composed of 224 participants. One trial was conducted on severely ill patients.

For the other sturdy composed of those who were moderately ill, some were given a placebo for the other research. In most cases, those who received Remdesivir only needed five days of therapy.

According to Mullane, they found the number of days that patients are required in the hospital was fewer than those who had the placebo arm. She added that the experiment showed that the faster someone gets the drug, the better.

Remdesivir is only available intravenously. That's why it is not easy to use except in the hospital, said Mullane. Besides, the FDA only gave the drug EUA.

Trump is also getting help from other lesser-familiar drugs, including an antibody cocktail from Regeneron.

Mullane said although the antibody cocktail is still experimental, it is helpful. "If I had a patient who presented to me who was ill and older and needed to be hospitalized, yes, I would certainly tell them to use both of those agents," she added.

Mullane is hopeful that the team's findings regarding Remdesivir could help convince the FDA to officially approve the drug to make it more widely available.