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20-11-2020 | COVID-19 | News

Regulatory update

FDA authorizes baricitinib combination for COVID-19

Author: Claire Barnard


medwireNews: The US FDA has issued an Emergency Use Authorization permitting the use of the Janus kinase (JAK) inhibitor baricitinib, in combination with remdesivir, for the treatment of COVID-19.

The authorization is based on a review of data from the ACTT-2 randomized trial, demonstrating better COVID-19 outcomes among patients treated with baricitinib plus remdesivir compared with those given placebo plus remdesivir, as well as data on the JAK inhibitor in patients with the approved indication of rheumatoid arthritis and other populations.

Baricitinib plus remdesivir may now be given to hospitalized adults or children aged 2 years and older with suspected or confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

“Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19,” says the FDA.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group

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