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25-06-2021 | Rheumatology | News | Article

approvalsWatch

FDA authorizes tocilizumab for severe COVID-19

Author:
Claire Barnard

medwireNews: The US FDA has issued an Emergency Use Authorization permitting the use of tocilizumab for the treatment of some hospitalized patients with severe COVID-19.

Currently approved by the FDA for the treatment of a number of rheumatic diseases, including rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, the interleukin-6 receptor inhibitor may now be given to patients with COVID-19 aged 2 years and older who are receiving systemic corticosteroids and require respiratory support with supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.

The Emergency Use Authorization is based on data from randomized controlled trials showing that add-on treatment with tocilizumab may reduce the risk for 28-day mortality and lower the duration of hospital stay in patients with severe COVID-19. The FDA notes that the supporting data came from four trials – RECOVERY, EMPACTA, COVACTA, and REMDACTA – with particular emphasis on data from RECOVERY and EMPACTA.

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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