Intellectual Thoughts !!!!!: May 2020


Saturday, May 2, 2020

FDA allows emergency use of drug remdesivir for COVID 19


The US Food and Drug Administration on Friday authorized Remdesivir (a nucleoside ribonucleic acid (RNA) polymerase inhibitor) an experimental antiviral drug, for emergency use to treat Covid-19.


The authorization allows the intravenous drug to be distributed to doctors to administer to patients with severe disease.

Many health experts have had high hopes for the drug, which was initially developed by Gilead Sciences to treat Ebola. In past,it was also  used in experiments to treat the coronaviruses SARS and MERS. That early testing gave remdesivir a head start in the race for a treatment to Covid-19.


The NIH trial, called the Adaptive COVID-19 Treatment Trial, included 1,063 patients. The results showed that the median time to recover for patients who randomly received the placebo was 15 days while patients who received remdesivir had a median recovery time of 11 days. Remdesivir also lowered the mortality rate compared to the placebo group, from 11.6 percent to 8 percent.

These results, however, are preliminary. There are at least 19 studies on remdesivir around the world underway or in planning stages, some recruiting thousands of patients. It will be several months before they yield definitive answers, but they will, hopefully, bring the world closer to a working treatment.

Earlier  a randomized trial of the drug in China recently published in the Lancet  found that there was no statistical benefit to taking the drug. The study  was based on a true randomized controlled trial from Wuhan, China, with 237 patients. The study was also peer-reviewed by other scientists. Initially, the authors wanted to include up to 450 patients, but the lockdown imposed in the city meant that patients stopped arriving.

The FDA on 28th March, 2020  had approved  emergency use authorization to a malaria drug, hydroxychloroquine, after President Donald Trump repeatedly promoted it as a possible treatment for COVID-19. 

Here is the link to the announcement.