It's not often that FDA backtracks on a decision, but in a surprising turn of events, the agency has reversed a decision on Amicus Therapeutics Inc.'s oral therapy for Fabry disease, migalastat, agreeing the company can submit an NDA for accelerated review based on existing data.
FDA Reversal Gives Amicus Renewed Hope For US Oral Fabry Launch
Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study. Additional information includes European submission data and post-launch RWE.
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