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U.S. FDA Files New Drug Application Under Priority Review for Migalastat for Treatment of Fabry Disease
Feb. 13, 2018 09:39AM PST
Biotech Investing
Amicus Therapeutics (Nasdaq:FOLD) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for filing under priority review for the oral precision medicine migalastat HCl (“migalastat”) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations. As quoted in the press release: Migalastat …
Amicus Therapeutics (Nasdaq:FOLD) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for filing under priority review for the oral precision medicine migalastat HCl (“migalastat”) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations.
As quoted in the press release:
Migalastat previously received both Orphan Drug Designation and Fast Track designation from the U.S. FDA. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.