ActivBiotics, Inc.

U.S. FDA fast track status granted for rifalazil in peripheral arterial disease

Published in Managed Care Law Weekly, March 5th, 2006

ActivBiotics, Inc., announced that it has been granted Fast Track designation by the U.S. Food & Drug Administration (FDA) for its lead product candidate, rifalazil, for the symptomatic treatment of peripheral arterial disease or (PAD).

Fast Track designation is reserved for new drugs that demonstrate the potential to address a significant unmet medical need and are intended for the treatment of a serious or life-threatening condition.

In citing reasons for granting the Fast Track designation, the agency noted that current approved treatments for PAD do not target underlying incipient contributors to disease progression, thought to be related to...

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Source: Managed Care Law Weekly (2006-03-05)

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