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11-03-2021 | Rheumatology | News | Article

approvalsWatch

FDA approves tocilizumab for SSc-ILD

Author:
Claire Barnard

medwireNews: Tocilizumab has been approved by the US FDA for slowing the rate of decline in respiratory function in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD).

Previously approved for a number of indications including rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, the interleukin-6 receptor inhibitor may now be given to adult patients with SSc-ILD at a dose of 162 mg once weekly by subcutaneous injection.

This expanded indication is based on findings from the phase 3 focuSSced trial, in which tocilizumab did not significantly improve skin fibrosis in patients with diffuse cutaneous SSc, but those treated with the agent had a significantly smaller decline in lung function than those given placebo.

The prescribing information for tocilizumab notes that the intravenous formulation has not been approved for SSc-ILD, and that dose interruption may be required for the management of laboratory abnormalities such as neutropenia, thrombocytopenia, and elevated liver enzymes.

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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