Aspreva says FDA fast-tracks CellCept lupus drug
LOS ANGELES, June 6 (Reuters) - Aspreva Pharmaceuticals Corp. ASPV.O on Wednesday said the U.S. Food and Drug Administration has granted "fast-track" status to its experimental drug CellCept for the treatment of lupus nephritis.
The FDA's 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. There has been no new approved treatment for lupus in the United States in over 30 years, the company said.
Aspreva is evaluating CellCept for the treatment of lupus nephritis in a global phase III study. Lupus nephritis is a complication of systemic lupus erythematosusis involving severe inflammation of the kidney and may progress rapidly to renal failure.
