28 November 2016 - Regulatory plan for full approval pathway based on generation of additional gastro-intestinal symptoms data.

Amicus Therapeutics announces its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat hydrochloride for Fabry disease. 

Following several collaborative discussions with the U.S. FDA, including the receipt of final written minutes from an in-person Type B meeting, the company plans to collect additional data on gastro-intestinal symptoms in Fabry patients who have an amenable mutation.

Read Amicus Therapeutics press release