Skip to main content
main-content
Top

30-07-2021 | Rheumatology | News | Article

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

30 July 2021: The coronavirus pandemic is affecting all healthcare professionals across the globe. Medicine Matters’ focus, in this difficult time, is the dissemination of the latest data to support you in your research and clinical practice, based on the scientific literature. We will update the information we provide on the site, as the data are published. However, please refer to your own professional and governmental guidelines for the latest guidance in your own country.

See the research in context now

with trial summaries, expert opinion and congress coverage