Granted Patent B2

US 8,357,371 · App. 13/095,234 · Granted Jan 22, 2013

Inventors: Mark W. Sleeman (Mahopac, NY); Joel H. Martin (Putnam Valley, NY); Tammy T. Huang (Goldens Bridge, NY); Douglas MacDonald (New York, NY); Gary Swergold (New Rochelle, NY)

Assignee: Regeneron Pharmaceuticals, Inc.

Abstract

Claims (16)

1. A method for treating hypercholesterolemia comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising an antibody or antigen-binding fragment thereof which specifically binds hPCSK9, wherein the antibody or antigen-binding fragment comprises the heavy and light chain CDRs of a HCVR/LCVR amino acid sequence pair selected from the group consisting of SEQ ID NOs:90/92 and 218/226.

2. The method of claim 1 , wherein the antibody or antigen-binding fragment comprises heavy and light chain CDR amino acid sequences having SEQ ID NOs:220, 222, 224, 228, 230 and 232.

3. The method of claim 2 , wherein the antibody or antigen-binding fragment comprises an HCVR having the amino acid sequence of SEQ ID NO:218 and an LCVR having the amino acid sequence of SEQ ID NO:226.

4. The method of claim 1 , wherein the antibody or antigen-binding fragment comprises heavy and light chain CDR amino acid sequences having SEQ ID NOs:76, 78, 80, 84, 86 and 88.

5. The method of claim 4 , wherein the antibody or antigen-binding fragment comprises an HCVR having the amino acid sequence of SEQ ID NO:90 and an LCVR having the amino acid sequence of SEQ ID NO:92.

6. The method of claim 1 , wherein the antibody or antigen-binding fragment binds to the same epitope on hPCSK9 as an antibody comprising heavy and light chain CDR amino acid sequences having SEQ ID NOs:220, 222, 224, 228, 230 and 232; or SEQ ID NOs: 76, 78, 80, 84, 86 and 88.

7. The method of claim 1 , wherein the antibody or antigen-binding fragment competes for binding to hPCSK9 with an antibody comprising heavy and light chain CDR amino acid sequences having SEQ ID NOs:220, 222, 224, 228, 230 and 232; or SEQ ID NOs: 76, 78, 80, 84, 86 and 88.

8. The method of claim 1 , wherein the patient is on a therapeutic statin regimen at the time of or just prior to administration of the pharmaceutical composition.

9. The method of claim 8 , wherein the therapeutic statin regimen comprises a statin selected from the group consisting of cerivastatin, atorvastatin, simvastatin, pitavastatin, rosuvastatin, fluvastatin, lovastatin and pravastatin.

10. The method of claim 9 , wherein the statin is atorvastatin.

11. The method of claim 1 , wherein the pharmaceutical composition comprises between 25 mg to 200 mg of the antibody or antigen-binding fragment thereof.

12. The method of claim 11 , wherein the pharmaceutical composition comprises 50 mg of the antibody or antigen-binding fragment thereof.

13. The method of claim 11 , wherein the pharmaceutical composition comprises 100 mg of the antibody or antigen-binding fragment thereof.

14. The method of claim 11 , wherein the pharmaceutical composition comprises 150 mg of the antibody or antigen-binding fragment thereof.

15. The method of claim 1 , wherein the patient has heterozygous Familial Hypercholesterolemia (heFH).

16. The method of claim 1 , wherein the patient has a form of hypercholesterolemia that is not Familial Hypercholesterolemia (nonFH).

Assignments (1)

Continuity (8)