FDA Moving at 'Lightning Speed' on Remdesivir Drug as Coronavirus Treatment


Data from a trial run by Gilead, also unveiled on Wednesday, showed similar clinical improvements in patients with severe symptoms of COVID-19, regardless of whether they received five or ten days of treatment.

Covid-19 patients who took the antiviral remdesivir recovered about 30 per cent faster than those on a placebo, the results of a major clinical trial showed Wednesday, as the top USA epidemiologist hailed the drug's "clear-cut" benefit.

The drug is called Remdesivir, and it's gaining praise from top health officials, including Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery", he said at a White House briefing.

While the data was less than stellar, they were hailed by USA health officials as highly significant since it clearly had an effect on the disease for which there are now no approved treatments of vaccines.

Remdesivir is an experimental antiviral drug being developed by Gilead Sciences. The top United States infectious disease expert revealed the early conclusion of an even bigger remdesivir study performed by the U.S. government. "This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials". Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.

The government-funded study found that patients who took remdesivir recovered faster than patients who did not.

Remdesivir is an intravenous, viral drug that has shown to shorten recovery time in 31 percent of treated patients, which Fauci has praised as a breakthrough despite the improvement not being "a knockout hundred percent".

As with the remdesivir trial that MultiCare is participating in, there are no placebo treatments.

That study concluded in 2019 when it was discontinued because it did not boost survival rates as greatly as two monoclonal antibody drugs, which are lab-engineered immune system proteins.

Early results of an global trial have revealed that the anti-inflammatory, anti-viral drug remdesivir, is a potential breakthrough.

The who has warned of the possibility of re infection COVID 19
More than 56,000 people have died in the United States, representing more than a quarter of all deaths worldwide. The total number of cases in mainland China now stands at 82,836, and deaths at 4,633.

Professor John Norrie from the University of Edinburgh, who was not involved in the study but commented on the trial, said that promising signals from observational data must be "rigorously confirmed or refuted" in trials as COVID-19 had "no proven safe and effective treatments" so far.

He also offered a few caveats.

What are the side effects of Remdesivir?

The results also suggested that people who were on the drug were less likely to die, although the difference was small.

"It is very important to understand that remdesivir and antivirals in general are not silver bullets", he said. "They do not immediately get rid of an infection". It works by interfering with the virus' ability to make more copies of itself.

The hopeful buzz around the drug Remdesivir and its potential as a COVID-19 treatment was so deafening Wednesday, it triggered an unexpected surge in the financial markets.

Remdesivir is made by Gilead Sciences, an American firm headquartered in Foster City, California.

The developments come as Froedtert Hospital in Wauwatosa announced they'll be using Remdesivir as a treatment for certain COVID-19 patients.

But Pitts warned that the drug has shown to a benefit for only the sickest of the sick - hospitalized patients who are elderly, have respiratory problems or preexisting health trouble. But the authors cautioned that the interpretation of their results is limited. A placebo control was not necessary to answer this question.

While the FDA issued emergency use authorization for serology tests this morning, no prospective timeline on when remdesivir will be added to the list of COVID-19 medical devices has been provided.