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Last Updated: April 19, 2024

Claims for Patent: 9,968,658


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Summary for Patent: 9,968,658
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:15/286,457
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,968,658
Patent Claims: 1. A method of treating an adult human patient having short bowel syndrome with elevated basal levels of endogenous GLP-2 (as compared to a normal healthy individual), who receives parenteral nutrition each week, and who presents with colon-in-continuity with remnant small intestine, said method comprising administering [Gly2]hGLP-2 to said patient using a dosing regimen effective to reduce or eliminate said weekly parenteral nutrition received by said patient.

2. The method of claim 1, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 5 to 500 .mu.g/kg.

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

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

5. The method of claim 4, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

6. A method of treating an adult human patient having short bowel syndrome with elevated basal levels of endogenous GLP-2 (as compared to a normal healthy individual), who receives parenteral nutrition each week, and who presents with colon-in-continuity with remnant small intestine, said method comprising administering [Gly2]hGLP-2 to said patient using a dosing regimen effective to increase wet weight absorption compared to a baseline wet weight absorption by said patient.

7. The method of claim 6, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 5 to 500 .mu.g/kg.

8. The method of claim 7, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg.

9. The method of claim 6, wherein the [Gly2]hGLP-2 is administered by subcutaneous injection.

10. The method of claim 9, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

11. A method for treating an adult human patient having short bowel syndrome with elevated basal levels of endogenous GLP-2 (as compared to a normal healthy individual) and who is dependent on parenteral nutrition, said method comprising administering to said patient [Gly2]hGLP-2 using a dosing regimen effective to enhance intestinal absorption by said patient.

12. The method of claim 11, wherein the GLP-2 receptor agonist is administered at a daily dose of from 5 to 500 .mu.g/kg.

13. The method of claim 12, wherein the GLP-2 receptor agonist is administered at a daily dose of from 30 to 150 .mu.g/kg.

14. The method of claim 11, wherein the GLP-2 receptor agonist is administered by subcutaneous injection.

15. The method of claim 14, wherein the subcutaneous injection is into the abdomen, thigh, or arm.

16. The method of claim 11, 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.

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

18. The method of claim 6, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

19. The method of claim 11, wherein said regimen comprises administration of said [Gly2]hGLP-2 over a period of at least 21 days.

20. The method of claim 1, wherein the parenteral nutrition is reduced by volume or frequency of administration.

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

22. The method of claim 6, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg by subcutaneous injection.

23. The method of claim 11, wherein the [Gly2]hGLP-2 is administered at a daily dose of from 30 to 150 .mu.g/kg by subcutaneous injection.

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