Baricitinib Gets Emergency Use Authorization by FDA

Baricitinib Gets Emergency Use Authorization by FDA

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Note: this drug must be used in combination with Remdesivir.

Baricitinib is currently approved in the US for moderate to severe rheumatoid arthritis that is refractory to tumor necrosis factor blockers. FDA has issued emergency used authorization (EUA) for it to be used in combination with Remdesivir.

FDA’s Emergency Use Authorization (EUA)
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19

Letter of authorization by FDA
https://www.fda.gov/media/143822/download

Clinical trial for Remdesivir and Baricitinib
https://www.niaid.nih.gov/news-events/nih-clinical-trial-testing-antiviral-remdesivir-plus-anti-inflammatory-drug-baricitinib

NIH concludes that Remdesivir and Baricitinib accelerate recovery
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
What is Baricitinib?
It is a JAK/STAT second messenger system inhibitor.
https://en.wikipedia.org/wiki/Baricitinib

How do JAK/STAT system work?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3616338/
https://en.wikipedia.org/wiki/JAK-STAT_signaling_pathway
ACTT-2 Trial that is used by NIH to recommend Remdesivir and Baricitinib
https://clinicaltrials.gov/ct2/show/NCT04401579

SOLIDARITY TRIAL that shows Remdesivir does not work
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1.full.pdf

https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
WHO asks to stop using Remdesivir
https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients

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