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FDA places Amicus's Pompe trial on hold due to safety concerns

This article was originally published in Scrip

Executive Summary

Amicus Therapeutics has suspended enrolment in its Phase II trial of its orphan drug candidate AT2220 (1-deoxynojirimycin HCl) for the treatment of Pompe disease, following a verbal request by the FDA after two patients reported serious adverse events which were probably related to treatment with the drug. The US agency has put the trial on clinical hold.

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