Aurinia Pharmaceuticals Inc. (AUPH) Tuesday said the U.S. Food and Drug Administration has approved a label update for LUPKYNIS, the company's approved medicine for the treatment of adult patients with active lupus nephritis (LN).
The label now includes three-year data from the AURORA 2 extension study which showed sustained complete renal response with LUPKYNIS through three years. The updated label does not state that the safety and efficacy of LUPKYNIS has not been established beyond one year.
The label also indicates that monthly kidney function assessment is no longer required after first year of treatment. The label had previously stated that it should be assessed every four weeks for the duration of treatment.
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