Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf

a technology of recombinant vwf and treatment of patients with severe von willebrand disease, which is applied in the direction of drug composition, extracellular fluid disorder, peptide/protein ingredient, etc., and can solve the problem of 1/10,000 patients actually needing treatmen

Inactive Publication Date: 2019-03-28
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0044]An advantage of the rVWF compositions of the present invention over pdVWF is that rVWF exhibits a higher specific activity than pdVWF. In some embodiments, the rVWF of the invention has a specific activity of at least about 20, 22.5, 25, 27.5, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60, 62.5, 65, 67.5, 70, 72.5, 75, 77.5, 80, 82.5, 85, 87.5, 90, 92.5, 95, 97.5, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150 or more mU / μg.

Problems solved by technology

However, excluding milder forms of the disease, only about 1 / 10,000 patients actually require treatment.

Method used

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  • Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf
  • Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf
  • Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf

Examples

Experimental program
Comparison scheme
Effect test

example 1

c Efficacy and Safety of rVWF

[0228]This study evaluated the hemostatic efficacy and safety of rVWF with or without ADVATE (antihemophilic factor [recombinant]), Baxalta US Inc., Westlake Village, Calif. (rFVIII) in patients with severe VWD undergoing elective surgery.

Methods

[0229]Phase 3, open-label, uncontrolled, nonrandomized study at 14 sites in 10 countries (NCT02283268) in patients ≥18 y of age who had severe VWD and were scheduled to undergo elective surgery. Patients were monitored for 14 d after surgery.

Treatment

[0230]12-24 h before surgery, rVWF 40-60 IU / kg rVWF:RCo was given intravenously to allow endogenous FVIII:C levels to increase to ≥30 IU / dL (minor / oral surgery) or ≥60 IU / dL (major surgery). FVIII:C levels were assessed within 3 h of initiation of surgery. If target FVIII:C levels were achieved, rVWF alone was administered 1 h before surgery to achieve the peak levels described in Table 2. If target FVIII:C levels were achieved, rVWF alone was administered 1 h before...

example 2

nt Von Willebrand Factor in Subjects with Severe Von Willebrand Disease Undergoing Surgery

[0245]This example provides the study results from a study examining treatment of subjects with severe von Willebrand Disease (VWD) undergoing surgery.

Outcome Measures:

Primary Outcome Measures:

[0246]Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) [Time Frame: 24 hours after last pen-operative infusion or at completion of Day 14 (±2 days) visit, whichever occurs earlier]. Hemostatic efficacy was rated on a scale of excellent—good—moderate—none.[0247]Excellent: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.[0248]Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject...

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Abstract

The present invention relates to method for pretreating a subject with severe von Willebrand disease prior to a surgical procedure comprising administering to the subject a dose ranging from about 20 IU / kg to about 60 IU / kg rVWF between about 12 hours and about 24 hours prior to the surgical procedure, and wherein Factor VIII is not administered with the rVWF prior to the surgical procedure.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Patent Application No. 62 / 546,999, filed on Aug. 17, 2017, and U.S. Provisional Patent Application No. 62 / 530,024, filed on Jul. 7, 2017, which are hereby incorporated by reference in their entirety.REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM, LISTING APPENDIX SUBMITTED ON A COMPACT DISK[0002]This disclosure incorporates by reference the Sequence Listing text copy submitted herewith, which was created on Oct. 1, 2018, entitled 008073_5186 US_ST25.txt which is 53 kilobytes in size.BACKGROUND OF THE INVENTION[0003]Coagulation diseases, such as von Willebrand Disease (VWD) generally result from a deficiency in the coagulation cascade. von Willebrand Disease (VWD) refers to the group of diseases caused by a deficiency of von Willebrand factor. Von Willebrand factor helps blood platelets clump together and stick to the blood vessel wall, which is necessary for normal blo...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/36A61P7/04
CPCA61K38/36A61P7/04
Inventor CHAPMAN, MIRANDAEWENSTEIN, BRUCEPLODER, BETTINA
Owner TAKEDA PHARMA CO LTD
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