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U.S. Food and Drug Administration

Amicus Therapeutics Announces FDA Agreement to Commence Phase 2 Study of AT2220 Co-administered with Enzyme Replacement Therapy for Pompe Disease

Published in Medical Letter on the CDC and FDA, March 27th, 2011

2011 MAR 27 -- Amicus Therapeutics (Nasdaq: FOLD) announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the AT2220 (1-deoxynojirimycin HCI) Investigational New Drug Application (IND). AT2220 is a pharmacological chaperone in development as a treatment for Pompe disease. Based on data provided by Amicus, the FDA agreed with the Company's proposal to resume clinical development of AT2220, starting with a new Phase 2 study designed to evaluate the use of AT2220 when co-administered with enzyme replacement therapy (ERT) in subjects with Pompe disease. The Company expects to commence this study in the first half of 2011 and to report...

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