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Last Updated: October 31, 2020

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Claims for Patent: 10,251,873

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Summary for Patent: 10,251,873
Title:Methods of treating fabry patients having renal impairment
Abstract: Provided are methods for treatment of Fabry disease in a patient having renal impairment and/or elevated proteinuria. Certain methods comprise administering to the patient about 100 to about 150 mg free base equivalent of migalastat or salt thereof at a frequency of once every other day. Certain methods also provide for the stabilization of renal function, reducing left ventricular mass index, reducing plasma globotriaosylsphingosine and/or increasing .alpha.-galactosidase A activity in the patient.
Inventor(s): Castelli; Jeff (New Hope, PA), Benjamin; Elfrida (Millstone Township, NA)
Assignee: Amicus Therapeutics, Inc. (Cranbury, NJ)
Application Number:15/992,336
Patent Claims: 1. A method of stabilizing renal function in a patient diagnosed with Fabry disease and having renal impairment, the method comprising administering to the patient an effective amount of migalastat or salt thereof at a frequency of once every other day, wherein the effective amount is about 100 mg to about 150 mg free base equivalent (FBE) wherein the administration of the migalastat or salt thereof is effective to stabilize renal function in the patient and wherein the patient has a HEK assay amenable mutation in .alpha.-galactosidase A.

2. The method of claim 1, wherein the patient has mild or moderate renal impairment.

3. The method of claim 1, wherein the patient has mild renal impairment.

4. The method of claim 1, wherein the patient has moderate renal impairment.

5. The method of claim 1, wherein the patient has severe renal impairment.

6. The method of claim 1, wherein the patient is an enzyme replacement therapy (ERT)-experienced patient.

7. The method of claim 1, wherein the patient is an enzyme replacement therapy (ERT)-naive patient.

8. The method of claim 1, wherein the patient has a proteinuria level of less than 100 mg/24hr prior to initiating the administration of the migalastat or salt thereof.

9. The method of claim 1, wherein the patient has a proteinuria level of 100 to 1,000 mg/24hr prior to initiating the administration of the migalastat or salt thereof.

10. The method of claim 1, wherein the patient has a proteinuria level of greater than 1,000 mg/24hr prior to initiating the administration of the migalastat or salt thereof.

11. The method of claim 1, wherein the migalastat or salt thereof is in a solid dosage form.

12. The method of claim 11, wherein the migalastat or salt thereof is administered orally.

13. The method of claim 1, wherein the migalastat or salt thereof is administered for at least 28 days.

14. The method of claim 1, wherein the migalastat or salt thereof is administered for at least 6 months.

15. The method of claim 1, wherein the migalastat or salt thereof is administered for at least 12 months.

16. The method of claim 1, wherein administration of the effective amount of the migalastat or salt thereof to a group of patients having mild or moderate renal impairment provides a mean annualized rate of change in eGFR.sub.CKD-EPI of greater than -1.0 mL/min/1.73 m.sup.2.

17. The method of claim 1, wherein administration of the effective amount of the migalastat or salt thereof to a group of patients having mild renal impairment provides a mean annualized rate of change in eGFR.sub.CKD-EPI of greater than -1.0 mL/min/1.73 m.sup.2.

18. The method of claim 1, wherein administration of the effective amount of the migalastat or salt thereof to a group of patients having moderate renal impairment provides a mean annualized rate of change in eGFR.sub.CKD-EPI of greater than -1.0 mL/min/1.73 m.sup.2.

19. The method of claim 1, wherein the effective amount is about 123 mg FBE.

20. The method of claim 1, wherein the effective amount is about 123 mg of migalastat free base.

21. The method of claim 1, wherein the effective amount is about 150 mg of migalastat hydrochloride.

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