FDA Has Given This Drug Emergency Authorization For COVID-19 Patients

The FDA has provided emergency authorization to some COVID-19 patients to use Remdesivir. The US Food and Drug Administration has given the go-ahead under the name of emergency authorization to an investigational antiviral drug known as remdesivir.

Remdesivir will be used for treating a number of children and adults that have been infected with COVID-19. The said drug will be administered once daily for up to 10 days and is reportedly capable of speeding up the recovery of patients. Daniel O’Day is the CEO of Gilead – the company behind Remdesivir and says that Gilead Sciences shall donate 1.5 million vials of the drug and will work in tandem with the federal government for quickly distributing it to the patients.

Issuing an EUA is different than FDA approval. In determining whether to issue an EUA, FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.

— Dr. Stephen M. Hahn (@SteveFDA) May 1, 2020

This happened days after a study concluded that the drug may help patients to recover faster. Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said, ‘The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recover.’ The previous study for Remdesivir and its effects was randomized and controlled. 1,063 patients suffering from advanced COVID-19 in 22 nations were given placebo or remdesivir. The patients that received the placebo recovered after 15 days whereas the group that had received the drug made a full recovery in 11 days.

The mortality rate for the group that received Remdesivir was also far lower than the group that was given a placebo. The study that was completed this week still needs peer review. Fauci said, ‘This is really quite important for a number of reasons. Although a 31% improvement doesn’t seem like a knockout, 100%, it is a very important proof of concept. What it has proven is that a drug can beat this virus.’

O’Day said, ‘’we’re still early days on the coronavirus, this is the first step today.’ The manufacturing time of this drug has been reduced to six months from twelve months. Gilead is among the list of several companies that are going all out to find the cure for this virus that has taken the whole world by surprise.