Aspreva announces Fast-Track designation granted by the FDA for CellCept

05102237

Aspreva Pharmaceuticals Corporation (Victoria) announced that the U.S. Food and Drug Administration has granted Fast Track designation for CellCept (mycophenolate mofetil, MMF) for the treatment of lupus nephritis. Aspreva is currently evaluating CellCept 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. There has been no new approved treatment for lupus in the United States in over thirty years. In granting Fast Track designation, the FDA noted that type III-V lupus nephritis is a severe inflammation of the kidney associated with systemic lupus erythematosus, and is a life-threatening disease. They continued stating that the partnership between Aspreva and Roche shows a commitment to study clinically important outcomes including death, need of dialysis, or loss of renal function in this serious disease. Finally 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.