IP Library › Granted Patent US 10,905,746
Granted Patent B2
US 10,905,746 · App. 16/802,118 · Granted Feb 2, 2021

Treatment of gastrointestinal bleeding in patients with severe von Willebrand disease by administration of recombinant VWF

Inventors: Miranda Chapman (Wellesley, MA); Bruce Ewenstein (Brookline, MA); Bettina Ploder (Vienna, AT)
Assignees: Baxalta GmbH; Baxalta Incorporated
A61K38/37A61K38/36A61P7/04
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Quick Facts
Patent No.
US 10,905,746
App. No.
16/802,118
Granted
Feb 2, 2021
Kind
B2
Abstract

The present invention relates to a method for treating gastrointestinal bleeding in a subject with severe von Willebrand Disease comprising administering to the subject at least one dose of recombinant von Willebrand Factor (rVWF) ranging from about 40 IU/kg to about 100 IU/kg, wherein the first dose further comprises recombinant Factor VIII (rFVIII).

Claims (36)

1. A method for treating gastrointestinal bleeding in a subject with severe von Willebrand Disease (VWD) comprising administering to the subject two doses of recombinant von Willebrand Factor (rVWF) each ranging from about 40 IU/kg to about 100 IU/kg, wherein the first dose further comprises recombinant Factor VIII (rFVIII).

2. The method of treatment of claim 1 , wherein said rFVIII is administered at a dose of about 20 IU/kg to about 50 IU/kg.

3. The method of treatment of claim 1 , wherein the second dose of rVWF does not comprise recombinant Factor VIII (rFVIII).

4. The method of treatment of claim 1 , wherein said rVWF to rFVIII ratio is about 1.5:0.8.

5. The method of treatment of claim 1 , wherein said rVWF to rFVIII ratio is about 1.3:1.

6. The method of treatment of claim 1 , wherein said rVWF to rFVIII ratio is about 1.1:0.8.

7. The method of treatment of claim 1 , wherein said rVWF to rFVIII ratio is about 1.5:1.

8. The method of treatment of claim 1 , wherein said rVWF to rFVIII ratio is about 1.1:1.2.

9. The method of treatment of claim 1 , wherein said rVWF is administered every 8 to 12 hours.

10. The method of treatment of claim 1 , wherein 40-60 IU/kg rVWF of said rVWF is administered in the first dose and wherein said gastrointestinal bleeding is minor or moderate gastrointestinal bleeding.

11. The method of treatment of claim 1 , wherein 40-80 IU/kg rVWF of said rVWF is administered in the first dose and wherein said gastrointestinal bleeding is major or severe gastrointestinal bleeding.

12. The method of treatment of claim 1 , wherein 40-60 IU/kg rVWF of said rVWF is administered every 8 to 12 hours and wherein said gastrointestinal bleeding is minor or moderate gastrointestinal bleeding.

13. The method of treatment of claim 1 , wherein 40-80 IU/kg rVWF of said rVWF is administered every 8 to 12 hours and wherein said gastrointestinal bleeding is major or severe gastrointestinal bleeding.

14. The method of treatment of claim 1 , wherein said subject has Type 3 VWD.

15. The method of treatment of claim 1 , wherein said subject has severe Type 1 VWD.

16. The method of treatment of claim 1 , wherein said subject has severe Type 2 VWD.

17. The method of claim 1 , wherein the subject had been treated for at least 1 bleeding event within the previous 12 months.

18. The method of claim 1 , wherein the subject had been treated for more than 1 bleeding event within the previous 12 months.

19. A method for treating gastrointestinal bleeding in a subject with severe von Willebrand Disease (VWD) comprising administering to the subject one dose of recombinant von Willebrand Factor (rVWF) ranging from about 40 IU/kg to about 100 IU/kg and one dose of recombinant Factor VIII (rFVIII).

20. The method of treatment of claim 19 , wherein said rFVIII is administered at a dose of about 20 IU/kg to about 50 IU/kg.

21. The method of treatment of claim 19 , wherein said rVWF to rFVIII ratio is about 1.5:0.8.

22. The method of treatment of claim 19 , wherein said rVWF to rFVIII ratio is about 1.3:1.

23. The method of treatment of claim 19 , wherein said rVWF to rFVIII ratio is about 1.1:0.8.

24. The method of treatment of claim 19 , wherein said rVWF to rFVIII ratio is about 1.5:1.

25. The method of treatment of claim 19 , wherein said rVWF to rFVIII ratio is about 1.1:1.2.

26. The method of treatment of claim 19 , wherein said rVWF is administered every 8 to 12 hours.

27. The method of treatment of claim 19 , wherein 40-60 IU/kg rVWF of said rVWF is administered and wherein said gastrointestinal bleeding is minor or moderate gastrointestinal bleeding.

28. The method of treatment of claim 19 , wherein 40-80 IU/kg rVWF of said rVWF and wherein said gastrointestinal bleeding is major or severe gastrointestinal bleeding.

29. The method of treatment of claim 19 , wherein said rVWF and said rFVIII are administered sequentially.

30. The method of treatment of claim 19 , wherein 40-60 IU/kg rVWF of said rVWF is administered, wherein 20-40 IU/kg rFVIII of said rFVIII is administered, and wherein said gastrointestinal bleeding is minor or moderate gastrointestinal bleeding.

31. The method of treatment of claim 19 , wherein 40-80 IU/kg rVWF of said rVWF is administered, wherein 20-40 IU/kg rFVIII of said rFVIII is administered, wherein said gastrointestinal bleeding is major or severe gastrointestinal bleeding.

32. The method of treatment of claim 19 , wherein said subject has Type 3 VWD.

33. The method of treatment of claim 19 , wherein said subject has severe Type 1 VWD.

34. The method of treatment of claim 19 , wherein said subject has severe Type 2 VWD.

35. The method of claim 19 , wherein the subject had been treated for at least 1 bleeding event within the previous 12 months.

36. The method of claim 19 , wherein the subject had been treated for more than 1 bleeding event within the previous 12 months.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2021
From: BAXALTA GMBH; BAXALTA INCORPORATED
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 055189/0177 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 24, 2020
From: CHAPMAN, MIRANDA; EWENSTEIN, BRUCE; PLODER, BETTINA
To: BAXALTA INCORPORATED; BAXALTA GMBH
Reel/Frame 052209/0892 →