medwireNews: The EMA’s Committee for Medicinal Products for Human Use has adopted a positive opinion on expanding the indication of belimumab to include lupus nephritis in Europe.
Previously approved as an add-on therapy for adult patients with active, autoantibody-positive systemic lupus erythematosus and high disease activity, the inhibitor of B-cell activating factor may now be given in combination with background immunosuppressive treatment for the treatment of adult patients with active lupus nephritis.
The efficacy of belimumab for lupus nephritis was demonstrated in the phase 3 BLISS-LN trial, in which adding belimumab to standard therapy improved renal outcomes.
The European announcement follows the approval of belimumab for lupus nephritis by the US FDA in December 2020.
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