Methods of reducing the risk of experiencing a cardiovascular (CV) event or a cerebrovascular event in a patient that has suffered a qualifying CV event

Patent metadata

Field	Value
Publication number	US-9683038-B2
Application number	US-201214347071-A
Country	US
Kind code	B2
Filing date	Sep 27, 2012
Priority date	Sep 30, 2011
Publication date	Jun 20, 2017
Grant date	Jun 20, 2017

Abstract

The present invention relates to an IL-1β binding antibody or a functional fragment thereof for use in preventing or reducing risk of experiencing a recurrent cardiovascular (CV) event or a cerebrovascular event in a patient that has suffered of a qualifying CV event.

First claim

The invention claimed is:

1. A method of reducing risk of experiencing a cardiovascular (CV) event or a cerebrovascular event in a stable patient who has had a prior myocardial infarction (MI), comprising subcutaneously administering 50 mg to 300 mg of an IL-1β binding antibody or functional fragment thereof to the patient every three months, wherein said patient has a hsCRP level of ≧2 mg/L before administration of said antibody or functional fragment thereof, and wherein said IL-1β binding antibody or functional fragment thereof comprises:
a) the three complementarity determining regions (CDRs) set forth as SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5 and the three CDRs set forth as SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8; or
b) a V H domain comprising SEQ ID NO:1 and a V L domain comprising SEQ ID NO:2.

2. The method according to claim 1 , wherein said IL-1β binding antibody or functional fragment thereof is first administered 2-5 weeks after the MI.

3. The method according to claim 1 , wherein said IL-1β binding antibody or functional fragment thereof is first administered 3 years after a CABG (Coronary Artery Bypass Graft) procedure.

4. The method according to claim 1 , wherein said CV event is selected from the group consisting of cardiovascular death and myocardial infarction (MI).

5. The method according to claim 1 , wherein said CV event is selected from the group consisting of hospitalization for unstable angina, acute coronary syndrome, other non-coronary ischemic event, any revascularization procedure, limb amputation, stent thrombosis, hospitalization or prolongation of hospitalization for heart failure, and coronary revascularization procedures.

6. The method according to claim 1 , wherein said cerebrovascular event is stroke.

7. The method according to claim 1 , wherein said method comprises administering 50 mg of the IL-1β binding antibody or functional fragment thereof.

8. The method according to claim 1 , wherein said method comprises administering 150 mg of the IL-1β binding antibody or functional fragment thereof.

9. The method according to claim 1 , wherein said method comprises administering 300 mg of the IL-1β binding antibody or functional fragment thereof.

10. The method according to claim 1 , wherein said IL-1β binding antibody or functional fragment thereof is capable of inhibiting the binding of IL-1β to its receptor and has a K D for binding to IL-1β of 50 pM or less.

11. The method according to claim 1 , wherein said IL-1β binding antibody is canakinumab.

12. A method of reducing the risk of experiencing cardiovascular death, stroke or myocardial infarction (MI) in a stable patient who has had a prior MI, comprising subcutaneously administering 50 mg-300 mg of canakinumab to the patient every three months, wherein said patient has a hsCRP level of ≧2 mg/L before administration of canakinumab.

13. A method of reducing the risk of experiencing cardiovascular death, stroke or myocardial infarction (MI) in a stable patient who has had a prior MI, comprising subcutaneously administering the patient 150 mg-300 mg of canakinumab at week 0 and week 2, and then every three months thereafter beginning at week 12.

14. The method of either claim 12 or 13 , wherein the first dose of canakinumab is administered no earlier than 28 days after the prior MI.

Assignees

• Thuren Tom
• Zalewski Andrew
• Shetzline Michael
• Novartis Ag

Inventors

• Thuren Tom
• Zalewski Andrew
• Shetzline Michael

Classifications

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• C07K2317/21

  from primates, e.g. man · CPC title

• C07K16/245 Primary

  IL-1 · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61K2039/505

  comprising antibodies · CPC title