Daily Management Review

Usage Of Remdesivir For Coronavirus Treatment Authorized By US FDA


Usage Of Remdesivir For Coronavirus Treatment Authorized By US FDA
Remdesivir, an experimental drug that has been proven to be able to help some patients of coronavirus to recover faster, was approved for usage in the pandemic under emergency conditions by the United States regulators.
This is the first medicine or treatment that that has shown it could help fight Covid-19, the disease caused by the novel coronavirus that has already killed more than 230,000 people globally.
United States Donald Trump made the announcement about the medicine at the White House with Stephen Hahn, the US Food and Drug Administration (FDA) Commissioner alongside. Hahn said the drug could be administered to patients who are hospitalized with Covid-19.
The evaluation of the drug was conducted by the FDA following a large test for the treatment that was sponsored by the government that showed that remdesivir, developed by the pharma giant Gilead Sciences, was able to reduce the time for recovery of Covid-19 patients by 31 per cent – or about 4 days on the average, administered for Covid-19 patients at hospitals.
The study for the effectiveness of the drug was conducted on 1,063 patients and was among the largest and the strictest clinical test for the drug ever conducted with respect to Covid-19. The test included use of a control group that was administered just the usual care so that the effects of remdesivir could be evaluated rigorously.
The study showed that the patients who were administered the drug were able to leave the hospital in 11 days on an average compared to an average time period of hospitalization of 15 days for those patients who were not administered the drug. Researchers also said that the drug could also possibly reduce deaths, even though that could not be ascertained on the basis of the partial results of the tests conducted that have been revealed so far.
For those severely ill patients of Covid-19 like those in the study, the drug will become a new standard, said Dr Anthony Fauci of the US National Institutes of Health. Patients with milder illness caused by the novel coronavirus pandemic were not administered the drug and it is currently administered through an IV in a hospital setting.
The FDA used its emergency powers to authorize the drug so that the entire process was sped up and a number of stages that an experimental drug has to go through are quickened so that such drugs could be available for patients during emergency public health crises.
There is need for "substantial evidence" of a drug's safety and effectiveness usually for the FDA to authorize their use for the general public. Typically, the stages demanded by the FDA require one or more large, rigorously controlled patient studies. But those standards could be waived during public health emergencies and the agency can simplify the requirements to only ensure that the benefits of an experimental drug’s administration are greater than the risks involved.
1.5 million vials of the drug will be donated to the US government by Gilead, the company said and is increasing production capacity of the drug to cater to an anticipated surge in demand.