Aspreva Pharmaceuticals Corp says that regulators in the USA have granted fast-track designation to CellCept, the Roche immunosuppressant that the Canadian firm is developing as a treatment for the most serious manifestation of lupus.
Aspreva is currently running a global Phase III study of CellCept (mycophenolate mofetil) for the treatment of lupus nephritis, a severe inflammation of the kidney associated with systemic lupus erythematosus, the chronic autoimmune disease that causes the body to attack its own tissues and joints.
The US Food and Drug Administration fast-track designation is designed to speed up the application and review process for products that have the potential to address a serious or life-threatening condition and this new indication of CellCept seems to fit the bill. There has been no new approved treatment for lupus in the USA in over 30 years, Aspreva said.
Aspreva's lupus nephritis Phase III study is one of the largest ever conducted in the disease and the company noted that it was designed as a randomised open-label comparison of CellCept with intravenous cyclophosphamide for the first six months followed by a double-blind comparison of the immunosuppressant to azathioprine for up to three years. The first patient of this study was treated in July 2005 and enrollment was completed at the end of September 2006 and Aspreva said that preliminary results are expected towards the end of this month.
In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights (excluding Japan) to develop and commercialise CellCept for all autoimmune disease applications.