Claims for Patent: 10,603,361

Summary for Patent: 10,603,361

Title:	Methods of treating a subject with an alkaline phosphatase deficiency
Abstract:	Disclosed herein are methods for treating a subject with an alkaline phosphatase deficiency, further comprising monitoring additional anaiytes, e.g., calcium, parathyroid hormone and/or vitamin D, with treatment modifications as indicated by the levels, e.g., serum levels, of the additional anaiytes.
Inventor(s):	Odrljin; Tatjana (Brookline, MA)
Assignee:	Alexion Pharmaceuticals, Inc. (Boston, MA)
Application Number:	15/544,063
Patent Claims:	1. A method of maintaining calcium homeostasis in a subject treated with an alkaline phosphatase for an alkaline phosphatase deficiency, wherein the alkaline phosphatase is asfotase alfa comprising the amino acid sequence of SEQ ID NO: 1, wherein the subject is determined to have a serum calcium concentration of less than 8.5 mg/dL comprising administering to the subject a therapeutic agent that increases the serum calcium concentration in the subject to 8.5 mg/dL or higher. 2. The method of claim 1, wherein the alkaline phosphatase deficiency is hypophosphatasia. 3. The method of claim 1, wherein the alkaline phosphatase is a tissue non-specific alkaline phosphatase, a placental alkaline phosphatase, an intestinal alkaline phosphatase, an engineered alkaline phosphatase, a fusion protein comprising an alkaline phosphatase moiety, or a chimeric alkaline phosphatase. 4. The method of claim 1, wherein, following administration of the therapeutic agent, the subject is determined to have a serum calcium concentration of higher than 10.5 mg/dL, and the method further comprises administering an additional therapeutic agent that reduces the serum calcium concentration in the subject to 10.5 mg/dL or lower. 5. The method of claim 1, wherein the method further comprises administering calcium or vitamin D to the subject, wherein the subject has a statistically significant low serum concentration of parathyroid hormone. 6. The method of claim 1, wherein the method further comprises administering vitamin D or a functional analog thereof to the subject, wherein the subject has a statistically significant low serum concentration of vitamin D. 7. The method of claim 2, further comprising administering vitamin D to the subject. 8. The method of claim 7, wherein the vitamin D is administered orally, intramuscularly, or intravenously. 9. The method of claim 1, wherein the alkaline phosphatase is administered in a dosage of from about 2 mg/kg/week to 9 mg/kg/week, or a comparable daily dosage. 10. The method of claim 1, wherein the therapeutic agent is calcium gluconate, or calcium chloride. 11. The method of claim 1, wherein the therapeutic agent is vitamin D or a functional vitamin D analog. 12. The method of claim 1, wherein the therapeutic agent is parathyroid hormone (PTH) or a functional PTH analog. 13. The method of claim 4, wherein the third therapeutic agent is wherein the therapeutic agent is a calcimimetic. 14. The method of claim 13, wherein the calcimimetic is cinacalcet. 15. The method of claim 4, wherein the additional therapeutic agent is a bisphosphonate. 16. The method of claim 4, wherein the additional therapeutic agent is prednisone. 17. The method of claim 4, wherein the additional therapeutic agent is an intravenous fluid. 18. The method of claim 4, wherein the additional therapeutic agent is a diuretic. 19. The method of claim 2, further comprising administering vitamin K to the subject. 20. The method of claim 2, further comprising administering vitamin B to the subject. 21. The method of claim 2, further comprising administering a multivitamin to the subject. 22. The method of claim 1, wherein the subject has a serum calcium concentration of 7.0 mg/dL or lower to 0.5 mg/dL or lower.

Details for Patent 10,603,361

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015	10,603,361	2036-01-28
Alexion Pharmaceuticals, Inc.	STRENSIQ	asfotase alfa	Injection	125513	October 23, 2015	10,603,361	2036-01-28