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US 12,606,638 B2Granted
Dosing regimens for use with PCSK9 inhibitors
AssigneesSanofi Biotechnology, Regeneron Pharamaceuticals, Inc.
InventorsMarie Baccara-Dinet, Laurence Bessac, Corinne Hanotin, Robert C. Pordy, William J. Sasiela, Jacques Rey
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Abstract
The present invention provides methods for treating a PCSK9-mediated disease or a PCSK9-mediated condition. Specifically, the invention relates to methods comprising the administration of a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody or antigen binding protein, in the absence of a statin, to a subject in need thereof.
Claims17
A method for reducing low-density lipoprotein cholesterol (LDL-C) in a subject in need thereof, the method comprising:
- (a) selecting a subject with primary hypercholesterolemia who is not taking a statin;
- and
- (b) administering to the subject a pharmaceutical composition comprising an anti-proprotein convertase subtilisin/kexin type 9 (anti-PCSK9) antibody or antigen-binding fragment thereof at a dose of about 300 mg every 4 weeks for at least 3 doses in the absence of a concomitant statin therapy, wherein the antibody or antigen-binding fragment thereof comprises the heavy and light chain complementarity determining regions (CDRs) of a heavy chain variable region/light chain variable region (HCVR/LCVR) amino acid sequence pair of SEQ ID NOs:
- 1/6,
- thereby reducing the LDL-C in the subject.
2 more elements
Dependencies are inferred from the claim text.