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Last Updated: March 28, 2024

Claims for Patent: 9,683,038


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Summary for Patent: 9,683,038
Title: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
Abstract: The present invention relates to an IL-1.beta. 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.
Inventor(s): Thuren; Tom (Succasunna, NJ), Zalewski; Andrew (Elkins Park, PA), Shetzline; Michael (Randolph, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:14/347,071
Patent Claims: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-1.beta. binding antibody or functional fragment thereof to the patient every three months, wherein said patient has a hsCRP level of .gtoreq.2 mg/L before administration of said antibody or functional fragment thereof, and wherein said IL-1.beta. 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.sub.H domain comprising SEQ ID NO:1 and a V.sub.L domain comprising SEQ ID NO:2.

2. The method according to claim 1, wherein said IL-1.beta. 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-1.beta. 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-1.beta. binding antibody or functional fragment thereof.

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

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

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

11. The method according to claim 1, wherein said IL-1.beta. 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 .gtoreq.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.

Details for Patent 9,683,038

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novartis Pharmaceuticals Corporation ILARIS canakinumab For Injection 125319 06/17/2009 ⤷  Try a Trial 2031-09-30
Novartis Pharmaceuticals Corporation ILARIS canakinumab Injection 125319 12/22/2016 ⤷  Try a Trial 2031-09-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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