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Methods of prophylactic treatment using recombinant vwf (RVWF)

A preventive, serious technology, applied in the direction of chemical instruments and methods, drug combinations, pharmaceutical formulations, etc., can solve problems such as preventive treatment is not well described or understood

Pending Publication Date: 2021-11-12
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, preventive treatments are not well described or understood

Method used

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  • Methods of prophylactic treatment using recombinant vwf (RVWF)
  • Methods of prophylactic treatment using recombinant vwf (RVWF)
  • Methods of prophylactic treatment using recombinant vwf (RVWF)

Examples

Experimental program
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preparation example Construction

[0254] k. Preparation methods of pharmaceutical preparations

[0255] The present invention also contemplates methods for the preparation of pharmaceutical formulations.

[0256] The method also includes one or more of the following steps: adding a stabilizer as described herein to the mixture prior to lyophilization; adding at least one selected from bulking agents, osmotic pressure regulators and Agents of surfactants, each as described herein, are added to the mixture.

[0257] Standard reconstitution practice for lyophilized material is to add back a volume of purified water or sterile water for injection (WFI) (usually equivalent to the volume removed during lyophilization), only in the preparation of drugs for parenteral administration Dilute solutions of antibacterial agents are sometimes used (Chen, Drug Development and Industrial Pharmacy, 18:1311-1354 (1992)). Accordingly, there is provided a method for preparing a reconstituted rVWF composition comprising the st...

Embodiment 1

[0316] Example 1: Efficacy and Safety of Recombinant Von Willebrand Factor (VWF) Prophylaxis in Severe Von Willebrand Disease (VWD): Design of a Prospective, Phase 3, Open-Label, International Multicenter Study

[0317] introduction

[0318] Patients with von Willebrand disease (VWD) have impaired hemostasis due to quantitative or qualitative defects in von Willebrand factor (VWF), a large multimeric plasma glycoprotein, It has key hemostatic functions that mediate platelet aggregation and stabilize circulating coagulation factor VIII (FVIII) (1-3). Most patients with VWD experience mild to moderate mucosal bleeding and hemorrhage after trauma or surgery, but life-threatening bleeding can also occur, especially in patients with severe disease (1,2).

[0319] Recombinant VWF (rVWF, vonicog alfa, VEYVONDI TM Baxalta Innovations GmbH, a Takedacompany, Vienna, Austria) was manufactured by recombinant DNA technology in Chinese hamster ovary cell lines without the addition of fo...

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Abstract

The present invention relates to a method for prophylactic treatment of spontaneous bleeding in a subject with severe von Willebrand Disease comprising administering a therapeutic amount of recombinant von Willebrand Factor (rVWF) to the subject.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 800,370, filed February 1, 2019, which is hereby incorporated by reference in its entirety. Background technique [0003] Coagulation disorders, such as von Willebrand Disease (VWD), are often caused by defects in the coagulation cascade. Von Willebrand disease (VWD) refers to a group of diseases caused by a deficiency in von Willebrand factor. Von Willebrand factor helps platelets clump together and stick to blood vessel walls, which is required for normal blood clotting. [0004] Von Willebrand disease (VWD) is the most common inherited bleeding disorder with an estimated prevalence of 1% (Veyradier A, et al., Medicine (Baltimore). 2016, 95(11):e3038). However, excluding the milder forms of the disease, only about 1 in 10,000 patients actually requires treatment. Current treatments for these coagulation disorders include replacement thera...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/36A61K38/37A61P7/04C07K14/745C07K14/755
CPCA61K38/36A61K38/37C07K14/755A61P7/04A61K9/0019G01N33/86G01N2333/755
Inventor B·梅尔加尔德B·埃文斯汀
Owner TAKEDA PHARMA CO LTD
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