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01-08-2022 | Rheumatology | News | Article

approvalsWatch

Voclosporin set for EMA approval for lupus nephritis

Author: Claire Barnard

medwireNews: Voclosporin has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use, recommending approval of the calcineurin inhibitor as an add-on treatment for lupus nephritis.

The benefits of voclosporin in this patient population were demonstrated in the phase 3 AURORA 1 trial, which found that adding the drug to background immunosuppressive therapy improves renal response rates.

The EMA recommends that voclosporin should be used in combination with mycophenolate mofetil for treating active class III, IV, or V lupus nephritis in adults.

This announcement follows the US FDA’s approval of voclosporin for lupus nephritis in 2021.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

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