Posted by Michael Wonder on 25 Sep 2017
U.S. FDA grants fast track designation for Amicus Therapeutics' migalastat for treatment of Fabry disease
19 September 2017 - New drug application submission on track for 4Q17.
Amicus Therapeutics announced that the U.S. FDA has granted fast track designation for the oral precision medicine migalastat for the treatment of patients with Fabry disease with amenable mutations. The FDA's fast track program is designed to expedite the development and review of drugs and biologics with the potential to treat serious or life-threatening conditions and with nonclinical or clinical data that demonstrate the potential to address unmet medical needs.
