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