FDA Talks Lead Amicus Therapeutics to Revamp Clinical Development of Migalastat

Amicus Therapeutics plans to conduct additional studies to support the approval of Migalastat for Fabry disease after the FDA rejected the company’s bids for accelerated approval and requested new data.

The company said it will conduct a 12-month study on Fabry patients who have an amenable mutation and GI symptoms. The study’s primary endpoint will be to assess diarrhea based on the FDA’s guidance for irritable bowel syndrome.