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Last Updated: April 26, 2024

Claims for Patent: 9,981,014


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Summary for Patent: 9,981,014
Title:Treatment of short bowel syndrome patients with colon-in-continuity
Abstract: Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.
Inventor(s): Sanguinetti; Elizabeth L. (Salt Lake City, UT), Marriott; Thomas B. (Sandy, UT), Lopansri; Jennifer (Park City, UT), Blosch; Consuelo M. (Seattle, WA)
Assignee: Shire-NPS Pharmaceuticals, Inc. (Lexington, MA)
Application Number:15/285,597
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,981,014
Patent Claims: 1. A method for treating an adult human patient with short bowel syndrome presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient [Gly2]hGLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient.

2. The method of claim 1, wherein the dosing regimen comprises daily administration of said [Gly2]hGLP-2.

3. The method of claim 2, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 5 to 500 .mu.g/kg.

4. The method of claim 3, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg.

5. The method of claim 1, wherein the [Gly2]hGLP-2 is administered by subcutaneous injection.

6. The method of claim 5, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

7. The method of claim 1, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

8. The method of claim 1, wherein the patient is dependent on parenteral nutrition.

9. A method for treating an adult human patient with short bowel syndrome presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient [Gly2]hGLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient; wherein the [Gly2]hGLP-2 is administered daily at a dose of from 30 to 150 .mu.g/kg by subcutaneous injection into the abdomen, thigh, or arm of said patient.

10. The method of claim 9, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

11. The method of claim 9, wherein the patient is dependent on parenteral nutrition.

12. A method for treating an adult human patient with short bowel syndrome who is dependent on parenteral nutrition and is presenting with colon-in-continuity with remnant small intestine, said method comprising administering to the patient [Gly2]hGLP-2 using a dosing regimen effective to enhance intestinal absorption by the patient.

13. The method of claim 12, wherein the [Gly2]hGLP-2 is administered daily at a dose of from 30 to 150 .mu.g/kg.

14. The method of claim 12, wherein the [Gly2]hGLP-2 administered by subcutaneous injection.

15. The method of claim 9, wherein the intestinal absorption is enhanced by an increase in wet weight absorption of at least 750 mL/day compared to a baseline wet weight absorption.

16. The method of claim 1, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

17. The method of claim 9, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

18. The method of claim 12, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

19. The method of claim 1, wherein said [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg by subcutaneous injection.

20. The method of claim 12, wherein said [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg by subcutaneous injection.

21. The method of claim 1, wherein said patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state.

22. The method of claim 12, wherein said patient retains colon sufficient to produce at least about 10% of endogenous GLP-2 levels produced by a healthy individual in a fed state.

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