Last Updated: May 11, 2026

Claims for Patent: 11,826,360

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Summary for Patent: 11,826,360

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:	US17/077,393
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,826,360
Patent Claims:	1. A composition comprising migalastat bound to an α-galactosidase A protein comprising a HEK assay amenable mutation selected from the group consisting of: D55G, H125Y, Q157H, L166S, N215I, K240N, G261R, L275V, N278Y, W287L, K308E and P343T wherein the composition further comprises globotriaosylceramide (GL-3). 2. The composition of claim 1, wherein the mutation is selected from the group consisting of: D55G, Q157H, L166S, N215I, K240N, G261R, L275V, N278Y, K308E and P343T. 3. The composition of claim 1, wherein the mutation is selected from the group consisting of: Q157H, L166S and K240N. 4. The composition of claim 1, wherein the mutation is selected from the group consisting of: D55G, H125Y, Q157H, L166S, N215I, K240N, G261R, L275V, N278Y, W287L and K308E. 5. The composition of claim 1, wherein the mutation is selected from the group consisting of: D55G, H125Y, Q157H, L166S, K240N, G261R, L275V, N278Y, W287L and K308E. 6. The composition of claim 1, wherein the mutation is selected from the group consisting of: D55G, Q157H, L166S, N215I, K240N, G261R, L275V, N278Y and K308E. 7. The composition of claim 1, wherein the migalastat stabilizes the α-galactosidase A protein. 8. The composition of claim 1, wherein the composition comprises white blood cells containing the GL-3 and the migalastat bound to the α-galactosidase A protein. 9. The composition of claim 1, wherein the composition comprises plasma containing the GL-3 and the migalastat bound to the α-galactosidase A protein. 10. The composition of claim 9, wherein the plasma contains migalastat at a concentration in the range of about 1 ng/mL to about 2191 ng/mL. 11. The composition of claim 9, wherein the plasma further comprises globotriaosylsphingosine (lyso-Gb3). 12. The composition of claim 11, wherein the plasma contains lyso-Gb3 at a concentration in the range of about 9.3 to about 13.1 nM/L. 13. A composition comprising migalastat bound to an α-galactosidase A protein comprising a HEK assay amenable mutation selected from the group consisting of: D55G, H125Y, Q157H, L166S, N2151, K240N, G261R, L275V, N278Y, W287L, K308E and P343T, wherein the composition comprises an organ containing migalastat bound to the α-galactosidase A protein. 14. The composition of claim 13, wherein the organ comprises a heart. 15. The composition of claim 13, wherein the organ comprises a kidney. 16. The composition of claim 13, wherein the organ comprises skin. 17. The composition of claim 1, wherein the composition comprises tissue containing the GL-3 and the migalastat bound to the α-galactosidase A protein. 18. The composition of claim 1, wherein the composition comprises cells containing the GL-3 and the migalastat bound to the α-galactosidase A protein. 19. The composition of claim 13, wherein the organ further comprises globotriaosylceramide (GL-3).

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