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Galafold Approval History

  • FDA approved: Yes (First approved August 10, 2018)
  • Brand name: Galafold
  • Generic name: migalastat
  • Dosage form: Capsules
  • Company: Amicus Therapeutics
  • Treatment for: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.

Development History and FDA Approval Process for Galafold

DateArticle
Aug 11, 2018Approval FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
Feb 12, 2018U.S. FDA Files New Drug Application Under Priority Review for Migalastat for Treatment of Fabry Disease
Dec 14, 2017Amicus Therapeutics Submits New Drug Application to U.S. FDA for Migalastat for Treatment of Fabry Disease
Sep 19, 2017FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease
Jul 11, 2017FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease
Nov 28, 2016Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease
Sep 15, 2015Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA
Feb 19, 2013Amicus Therapeutics Presents Additional 6-Month Results from Phase 3 Fabry Monotherapy Study at LDN World Symposium
Feb 16, 2011Amicus Therapeutics Provides Positive Data Update from Phase 2 Long-Term Extension Study of Amigal for Fabry Disease
Feb 12, 2010Amicus Therapeutics Presents Positive Data Update From Phase 2 Extension Study of Amigal for Fabry Disease
Mar 30, 2009Amicus Therapeutics Presents Positive Results From Phase 2 Extension Study of Amigal for Fabry Disease at ACMG 2009 Annual Meeting
Aug  4, 2008Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease
Dec 20, 2007Amicus Therapeutics Announces Positive Results From Phase 2 Clinical Trials of Amigal for Fabry Disease
Mar 19, 2007Amicus Therapeutics Presents Data From Preclinical and Phase 1 Studies of Amigal for Fabry Disease

Further information

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