# US 2004/0006021 A1 · Pharmaceutical composition comprising factor Vll polypeptides and tranexamic acid

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- Number: US 2004/0006021 A1
- Document ID: US20040006021A1
- Status: Published application
- Kind: A1
- Application number: 10/437,674
- Filed: 2003-05-14
- Published: 2004-01-08
- Earliest claimed: 2001-11-09
- Inventors: Rasmus Rojkjaer
- Web page: https://patentgrep.com/patent/US20040006021A1

## CPC

- A61K 38/4846: {Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)}
- A61K 31/195: having an amino group
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Y 304/21021: Coagulation factor VIIa (3.4.21.21)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES

## Abstract

The present invention relates to a composition comprising factor VII or a factor VII-related poly-peptide and tranexamic acid, and the use thereof for treating bleeding episodes.

## Claims

### Claim 1

A pharmaceutical composition comprising a factor VII-related polypeptide and tranexamic acid.

### Claim 2 (depends on 1)

A composition according to claim 1, wherein said factor VII-related polypeptide is a factor VII amino acid sequence variant.

### Claim 3 (depends on 1)

A composition according to claim 1, wherein the ratio between the activity of said factor VII-related polypeptide and the activity of native human factor VIIa (wild-type FVIIa) is at least about 1.25 when tested in an In Vitro Hydrolysis Assay.

### Claim 4 (depends on 1)

A composition according to claim 1, wherein said factor VII-related polypeptide and said tranexamic acid are present in a ratio of between about 100:1 and about 1:100 (w/w factor VII:tranexamic acid)

### Claim 5 (depends on 1)

A composition according to claim 1 wherein the composition further comprises one or more pharmaceutically acceptable excipients suitable for injection or infusion.

### Claim 6

A kit comprising
a) A preparation of a factor VII-related polypeptide and a pharmaceutically acceptable carrier in a first-unit dosage form;
b) A preparation of tranexamic acid and a pharmaceutically acceptable carrier in a second-unit dosage form; and
c) Container means for containing said first and second dosage forms.

### Claim 7

A kit comprising
a) An effective amount of a factor VII-related polypeptide and an effective amount of tranexamic acid and a pharmaceutically acceptable carrier in a single-unit dosage form; and
b) Container means for containing said single-unit dosage form.

### Claim 8

A method for treating bleeding in a non-haemophilic subject in need of such treatment, the method comprising administering to the subject a first amount of a preparation of factor VII and a second amount of a preparation of tranexamic acid, wherein the first and second amount together are effective to treat said bleeding episode.

### Claim 9 (depends on 8)

A method according to claim 8, wherein said treatment comprises reducing clotting time and the method comprises administering to the subject a first amount of a preparation of factor VII and a second amount of a preparation of tranexamic acid wherein the first and second amount together are effective to reduce clotting time.

### Claim 10 (depends on 8)

A method according to claim 8, wherein said treatment comprises enhancing haemostasis and the method comprises administering to the subject a first amount of a preparation of factor VII and a second amount of a preparation of tranexamic acid wherein the first and second amount together are effective to enhance haemostasis.

### Claim 11 (depends on 8)

A method according to claim 8, wherein said treatment comprises prolonging clot lysis time and the method comprises administering to the subject a first amount of a preparation of factor VII and a second amount of a preparation of tranexamic acid wherein the first and second amount together are effective to prolong the clot lysis time.

### Claim 12 (depends on 8)

A method according to claim 8, wherein said treatment comprises increasing clot strength and the method comprising administering to the subject a first amount of a preparation of factor VII and a second amount of a preparation of tranexamic acid wherein the first and second amount together are effective to increase clot strength.

### Claim 13 (depends on 8)

A method according to claim 8, wherein said factor VII and said tranexamic acid are administered in single-dosage form.

### Claim 14 (depends on 8)

A method according to claim 8, wherein said factor VII is administered in the form of a first-unit dosage form comprising a preparation of factor VII, and said tranexamic acid is administered in the form of a a second-unit dosage form comprising a preparation of tranexamic acid.

### Claim 15 (depends on 14)

A method according to claim 14, wherein the first dosage form and the second dosage form are administered with a time separation of no more than 15 minutes.