Lupus Nephritis

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

Published in Medical Letter on the CDC and FDA, June 24th, 2007

Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) announced that the U.S. Food and Drug Administration (FDA) 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...

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Source: Medical Letter on the CDC and FDA (2007-06-24)

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