Claims for Patent: 11,357,784

Summary for Patent: 11,357,784

Title:	Use of migalastat for treating Fabry disease in pregnant patients
Abstract:	Provided are methods of treating a patient diagnosed with Fabry disease. Certain methods treat a pregnant patient with a therapeutically effective dose of migalastat or a salt thereof. Other methods treat a patient of childbearing potential with a therapeutically effective dose of migalastat or a salt thereof. Also described are the successful outcomes of pregnancies during which the pregnant patient is treated with migalastat.
Inventor(s):	Jay Barth
Assignee:	Amicus Therapeutics Inc
Application Number:	US16/967,827
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,357,784
Patent Claims:	1. A method for the treatment of Fabry disease in a pregnant patient in need, the method comprising administering to the patient a formulation comprising a therapeutically effective dose of about 100 mg to about 150 mg free base equivalent (FBE) of migalastat or a salt thereof at a frequency of once every other day. 2. The method of claim 1, further comprising administering to the patient the formulation at a frequency of once every other day during a pre-pregnancy treatment period before the patient becomes pregnant. 3. The method of claim 2, wherein the patient was not instructed to use effective birth control during the pre-pregnancy treatment period. 4. The method of claim 2, wherein the patient was not utilizing effective birth control during the pre-pregnancy treatment period. 5. The method of claim 1, wherein the patient is pregnant before initiating the treatment. 6. The method of claim 5, wherein the patient is not known to be pregnant before initiating the treatment. 7. The method of claim 1, wherein the treatment is discontinued upon identification of the patient's pregnancy. 8. The method of claim 5, wherein the patient is known to be pregnant before initiating the treatment. 9. The method of claim 1, wherein the patient's pregnancy results in a birth of a child having a gestational age of at least 37 weeks. 10. The method of claim 1, wherein the patient's pregnancy results in a birth of a child of normal weight based on a gestational age of the child. 11. The method of claim 1, wherein the patient's pregnancy results in a child without a birth defect. 12. The method of claim 1, wherein the therapeutically effective dose is about 123 mg free base equivalent (FBE) of migalastat or a salt thereof. 13. The method of claim 1, wherein the therapeutically effective dose is about 123 mg of migalastat free base. 14. The method of claim 1, wherein the salt of migalastat is migalastat hydrochloride. 15. The method of claim 14, wherein the therapeutically effective dose is about 150 mg of migalastat hydrochloride. 16. The method of claim 1, wherein the formulation is administered for at least 6 weeks during the pregnancy. 17. The method of claim 1, wherein the formulation is administered during a first trimester of the patient's pregnancy. 18. The method of claim 1, wherein the formulation is administered during a second trimester of the patient's pregnancy. 19. The method of claim 1, wherein the formulation is administered during the first 16 weeks of the patient's pregnancy. 20. The method of claim 3, wherein the patient was not utilizing effective birth control during the pre-pregnancy treatment period.