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Last Updated: December 19, 2025

Claims for Patent: 11,357,765

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Summary for Patent: 11,357,765

Title:	Methods of treating Fabry patients having renal impairment
Abstract:	Provided are methods for treatment of Fabry disease in patients having HEK assay amenable mutations in α-galactosidase A. Certain methods comprise administering migalastat or a salt thereof every other day, such as administering about 150 mg of migalastat hydrochloride every other day.
Inventor(s):	Jeff Castelli, Elfrida Benjamin
Assignee:	Amicus Therapeutics Inc
Application Number:	US17/670,088
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,357,765
Patent Claims:	1. A molecule comprising migalastat bound to an α-galactosidase A protein comprising a HEK assay amenable mutation selected from the group consisting of A13P, L89F, Y200C, G271D, W277C and F337S. 2. The molecule of claim 1, wherein the mutation is A13P. 3. The molecule of claim 1, wherein the mutation is L89F. 4. The molecule of claim 1, wherein the mutation is Y200C. 5. The molecule of claim 1, wherein the mutation is G271D. 6. The molecule of claim 1, wherein the mutation is W277C. 7. The molecule of claim 1, wherein the mutation is F337S. 8. The molecule of claim 1, wherein the mutation is a disease-causing mutation. 9. An α-galactosidase A protein having a HEK amenable mutation selected from the group consisting of A13P, L89F, Y200C, G271D, W277C and F337S wherein the protein has increased stability as compared to a naturally-occurring α-galactosidase A protein having the same mutation. 10. The α-galactosidase A protein of claim 9, wherein the protein is bound to migalastat. 11. The α-galactosidase A protein of claim 9, wherein the mutation is A13P. 12. The α-galactosidase A protein of claim 9, wherein the mutation is L89F. 13. The α-galactosidase A protein of claim 9, wherein the mutation is Y200C. 14. The α-galactosidase A protein of claim 9, wherein the mutation is G271D. 15. The α-galactosidase A protein of claim 9, wherein the mutation is W277C. 16. The α-galactosidase A protein of claim 9, wherein the mutation is F337S. 17. The α-galactosidase A protein of claim 9, wherein the mutation is a disease-causing mutation.

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