https://www.fda.gov/media/137564/download


Good news. Fast tracked.

No, not approved for the treatment of any disease. This is "just" an EUA. Big difference.

Medicare and insurers will pay claims for it, so yeah its approved - just not in the traditional sense.

Sigh...this board is supposed to be for factual information, let's try to use the proper terms when we can.

Remdesivir is not approved for the treatment of any indication. It says so in the EUA.

The term "fast track" also has specific meaning. Remdesivir and many other potential COVID-19 therapies were granted Fast-Track when they submitted their INDs. That allows for faster review times and more ongoing communication with the FDA during the development process. That is separate from this EUA.

As an example of why this distinction is important, the EUA can and will eventually be rescinded. If remdesivir is not yet approved for any indication at that time, it will revert to only being available via clinical trials and compassionate use/expanded access programs.

This same thing happened during H1N1. Peramivir, promising new IV antiviral, not yet approved for any indication, was granted EUA in October of 2009 based on some preliminary data. That order was rescinded in June 2010 because the emergency was deemed over. It then took BioCryst, the makers of peramivir, until December 2014 to gain it's first FDA approval.

So yes, I feel it is important to use the correct terminology so as not to be misleading.

Thank you for that Nawlins, that will be very helpful information the physicians can use to explain the difference to dying patients.

saltgap said:

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Thank you for that Nawlins, that will be very helpful information the physicians can use to explain the difference to dying patients.

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If physicians are coming here to gain information on how to treat dying patients, then we're in worse shape then I thought

jt16 said:

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saltgap said:

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Thank you for that Nawlins, that will be very helpful information the physicians can use to explain the difference to dying patients.

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If physicians are coming here to gain information on how to treat dying patients, then we're in worse shape then I thought

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You missed the sarcasm there. My whole point was that regardless of what you define the FDA's action as, the most important thing is its an option for physicians to utilize now.

jt16 said:

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saltgap said:

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Thank you for that Nawlins, that will be very helpful information the physicians can use to explain the difference to dying patients.

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If physicians are coming here to gain information on how to treat dying patients, then we're in worse shape then I thought

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There's been at least 1 situation of a physician posting on this board unable to get a drug. Another poster was able to secure the drug for them and get it into their hospital.

Several physician have been posting their stories on which medications they've tried, treatments, etc.

I don't understand why these are bad things. This thing is novel and treatments are changing very rapidly.

Maybe my OP was misleading. But literally it WAS approved. For emergency use. I didn't state that. Sorry. But, I did post the link with details. But the main point is it is now possible to Rx it outside of a clinical trial. It's important info to feed along. Which is the purpose of this board. I have learned a ton from other docs on here. This thing is novel. The China and Seattle recommendations for treatment were inaccurate. I now have a firm grip on how to manage these very sick patients. And a lot of that has been from interacting with others on this board. Don't underestimate or belittle it. The criticisms and backlash from some on here are unwarranted IMO.

Amen, keep up the good fight brother