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30-07-2021 | COVID-19 | News

Regulatory update

Baricitinib monotherapy gains FDA authorization for COVID-19

Author: Claire Barnard


medwireNews: The US FDA has updated its Emergency Use Authorization (EUA) for baricitinib, and the Janus kinase (JAK) inhibitor is now permitted to be used for the treatment of COVID-19 without the requirement for remdesivir co-medication.

Based on a review of results from the ACTT-2 and COV-BARRIER trials, as well as data in patients treated for rheumatoid arthritis, the FDA says “it is reasonable to believe” baricitinib may be beneficial for hospitalized adults and children aged 2 years and older with COVID-19 who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

“[T]he known and potential benefits of baricitinib when used to treat COVID-19 in such patients […] outweigh the known and potential risks,” the agency adds.

The initial EUA permitting the use of baricitinib in combination with remdesivir for COVID-19 was issued in November 2020.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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