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FDA Rolls Out Emergency Compassionate Use Authorization For Remdesivir

By Hank Campbell in Science 2.0
April 29, 2020
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Submitted by Hank on Wed, 04/29/2020 - 11:58
Old NID
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Though a study by the Chinese government hoped to throw cold water on the potential for Gilead's remdesivir to treat the most dangerously ill COVID-19 patients, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said their group is optimistic about the experimental antiviral drug after its analysis of results and the US FDA has indicated it is ready to bypass their usual mountain of paperwork to allow it for a "compassionate use" exemption.

Originally created for Ebola,
remdesivir is not approved globally for any human condition yet but works using in vitro and in vivo animal models. It can stop a virus from multiplying so it was tried against SARS, MERS, and SARS-CoV-2 coronaviruses and it succeeded. After case studies also reported benefit in severely ill COVID-19 patients, clinical trials started.

But clinical trials require placebo and it has no safety issues so it makes more sense for FDA to allow it under Compassionate Use and get real data that way. A recent study also showed it didn't require 10 days to help.

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