Remdisivir gets full approval - Printable Version
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Remdisivir gets full approval - BostonCard - 10-22-2020
Remdisivir had been operating under an EUA; it has now received full FDA approval.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19
Which is interesting, because the WHO recently announced that remdisivir had no effect in a very large study (much larger that ACTT, which was sponsored by the NIH and showed improvement in time to recover).
https://www.sciencemag.org/news/2020/10/remdesivir-and-interferon-fall-flat-who-s-megastudy-covid-19-treatments
BC
RE: Remdisivir gets full approval - OutsiderFan - 10-22-2020
I wouldn't be taking this drug if I had Covid infection.
RE: Remdisivir gets full approval - dabigv13 - 10-22-2020
I'd probably take it, it at least seems safe and maybe could help a bit.
I wonder BC, have you seen many drugs get FDA approval when the efficacy data is this poor?
RE: Remdisivir gets full approval - BostonCard - 10-22-2020
(10-22-2020, 04:27 PM)dabigv13 Wrote: I'd probably take it, it at least seems safe and maybe could help a bit.
I wonder BC, have you seen many drugs get FDA approval when the efficacy data is this poor?
In the oncology space, a number of drugs have gotten "accelerated approval" from the FDA. A recent JAMA article (https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2733561) found that only about 1/5 of them had confirmatory trials that showed a survival advantage.
Quote:Conclusions and Relevance Confirmatory trials for one-fifth (n = 19 of 93) of cancer drug indications approved via the FDA’s accelerated approval pathway demonstrated improvements in overall patient survival. Reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.
BC
RE: Remdisivir gets full approval - OutsiderFan - 10-29-2020
Oh, look:
[tweet]https://twitter.com/EricTopol/status/1321594820243017729[/tweet]
RE: Remdisivir gets full approval - magnus - 10-29-2020
(10-29-2020, 06:17 AM)OutsiderFan Wrote: Oh, look:The tweet disappeared, but the article is still there:
[tweet]https://twitter.com/EricTopol/status/1321594820243017729[/tweet]
https://www.sciencemag.org/news/2020/10/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug