Aspreva lupus treatment fast-tracked by FDA

Aspreva is currently evaluating CellCept, known generically as mycophenolate mofetil, for the treatment of lupus nephritis in a global phase III study.

The FDA’s fast track designation is designed to expedite the application and review process for products that have the potential to address a serious or life-threatening condition. Aspreva reported that there has been no new approved treatment for lupus in the US in over 30 years.

Type III-V lupus nephritis is a severe inflammation of the kidney associated with systemic lupus erythematosus, and is a life-threatening disease.

Aspreva said that the FDA noted that CellCept received fast track designation on the basis that, given the current development program in lupus nephritis, it may have the potential to address an unmet medical need in patients with this disease.

Aspreva also said that the FDA had recognized that its partnership with Roche shows a commitment to study clinically important outcomes including death, need of dialysis, or loss of renal function in this serious disease.

“Lupus nephritis is one of the most serious manifestations of lupus, and if left untreated can result in progressive kidney failure,” said Dr Usman Azam, Aspreva’s executive vice-president and chief medical officer. “We believe that fast track designation from the FDA will be of great assistance in our efforts to bring an evidence-based treatment option to this patient population where there is a clear unmet medical need.”