Aspreva, Roche Update Lupus Nephritis Development Program

Aspreva Pharmaceuticals announced that it and Roche have decided not to proceed with a regulatory submission for CellCept as an induction therapy for lupus nephritis at this time.

Preliminary results from the induction stage of Aspreva’s Phase III clinical trial comparing CellCept (oral mycophenolate mofetil) with intravenous cyclophosphamide were released in June. These initial results showed that, although response rates were similar in both arms of the study, the induction stage of the trial did not meet its primary objective of demonstrating that CellCept was superior to intravenous cyclophosphamide in inducing treatment response, Aspreva and Roche said.

The patients who successfully completed the induction phase of the lupus nephritis study were rerandomized into the maintenance phase, a blinded study comparing CellCept with azathioprine in maintaining remission and renal function in subjects with lupus nephritis.

The trial will last either a maximum of 36 months or until a predetermined number of patients have left the study.