FDA approves first drug for Covid-19: remdesivir
S E E D E D C O N T E N T
The Food and Drug Administration approved remdesivir to treat Covid-19 on Thursday, making it the first and only drug so far to have received federal approval for the coronavirus.
The drug, made by Gilead Sciences, had been granted emergency use authorization by the FDA in May. But to get full FDA approval, a drugmaker must submit additional evidence to support safety and efficacy.
Remdesivir is now approved for patients over age 12 who are hospitalized with Covid-19. It is given intravenously, generally for five days.
An emergency use authorization meant physicians could give the drug to hospitalized Covid-19 patients, but they had to go through an extensive consent process with patients' families before doing so.
Thursday's approval is expected to streamline and ease the process for doctors.
Oct. 3: Trump treated with remdesivir after coronavirus diagnosis
Daniel O'Day, Gilead's CEO, said in a statement that "it is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as Covid-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need."
Gilead will sell the drug under the brand name Veklury.
Remdesivir is an antiviral drug, meaning it is thought to work by lowering the amount of virus in the body. The drug has been shown to do so in laboratory studies and animals; however, it has not been proven to work that way in humans.
A National Institutes of Health-funded clinical trial found that the drug reduced the length of hospital stays among patients with moderate illness by about four days, from 15 to 11 days.
Remdesivir has not been shown to significantly lower the mortality rate of Covid-19. And recently, the World Health Organization released preliminary data showing that the drug did not benefit the very sickest Covid-19 patients. The finding did not surprise many infectious disease experts, who say antivirals such as remdesivir usually work best if they are administered early.
President Donald Trump received a course of the drug when he was treated for Covid-19 this month.
Tags
Who is online
63 visitors
The (modest) beginning of the road to recovery from the pandemic.
A National Institutes of Health-funded clinical trial found that the drug reduced the length of hospital stays among patients with moderate illness by about four days, from 15 to 11 days.
Well if it works as claimed, while its not a cure, nor a preventative-- its good if it reduces the length of hospital stays by a few days.
I don't think I've ever seen so many different pharmaceutical companies suddenly all working on a vaccine for the same specific illness, all starting at about the same time, working 'round. the clock. And they are taking several different approaches. (All of which is a good thing, but it will still take more time...).
I thought the WHO just declared this dug almost useless against COVID?
Russia too?
Don't know what to say. Did the FDA just approve a drug that does nothing? Does this mean that our modest beginning is complete bullshit and that the FDA is effectively playing games?
Who knows anymore?
Apparently so, at least as far as COVID-19 is concerned.
Everything in this Administration is tainted by the WH.
There no longer is any objectivity or independence among the various agencies, especially those headed by political appointees with little experience which alter scientific documents and web sites to please the President instead of informing the public.
"It is what it is" D.J.Trump
Well they already did that with Hydroxychloroquine. The US bought 6+ million doses and are stuck with them now. They are doing the same with Rendesivir. So far as I can find, 4.5 Millions of doses @ $390 a pop. In short, Gilead has already recouped the 1 BILLION they claim to have invested from the doses sold to the US alone. This even though the US funded some of the development and the US study...
Let's see if they revoke this as they did with their temporary emergency use of Hydroxychloroquine for COVID-19 treatment.
This has been ongoing since before May 1st when Trump announced the 'acquisition' of 1.5 Million doses of Remdesivir. Allegedly, the US government was going to 'donate' them. That's about 250,000 courses of the drug and I at least haven't heard anything about it since then. Then in July, they announced the 'acquisition' of another 500,000 courses, which is 3 MILLION doses. Nothing much about the 'donation' thingy in that announcement. That would mean that 3/4 of a million would have received Remdesivir in the US since May JUST from the US government's stock but I can't find any documentation that proves that out. I guess the studies that the US funded could have sucked up quite a few of the original 'donation' but who knows...
The FDA approved remdesivir to treat Covid-19. Remdesivir is the first drug to receive FDA approval.
It should be pointed out that that's "Emergency Use Approval". More details here:
Remdesivir for the Treatment of Covid-19 — Final Report