Regeneron Pharmaceuticals, Inc.

Sanofi Biotechnology

Robert C Pordy

William J Sasiela

Laurence Bessac

Corinne Hanotin

Stephen Donahue

Marie Baccara-Dinet

Umesh Chaudhari

Gary Swergold

Garen Manvelian

Xiaobing Qian

Daniel A Schwemmer Gipe

Joel H Martin

Tammy T Huang

Douglas MacDonald

Mark W Sleeman

Gary Herman

Philippe Gabriel Steg

Gregory G Schwartz

Jacques Rey

Daniel A Schwemmer-Gipe

The disclosure provides compositions, kits, and methods of using a GDF-8 inhibitor to increase lean muscle mass. In embodiments, a GDF-8 inhibitor is an antibody or antigen binding fragment thereof that specifically binds GDF-8. In embodiments, a method comprises providing an exercise regimen for the subject, and administering a composition comprising an effective amount of a GDF-8 inhibitor.

Methods for increasing lean body mass with an exercise regimen and a GDF8 inhibitor that is an anti-GDF8 antibody

The present invention provides methods for reducing or eliminating a patient's need for lipoprotein apheresis therapy. The methods of the present invention comprise administering to a patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody. The methods of the present invention are useful for treating patients with hyperlipidemia and related conditions who are currently being treated with a therapeutic regimen comprising lipoprotein apheresis (e.g., LDL apheresis or Lp(a) apheresis).

Methods for reducing or eliminating the need for lipoprotein apheresis in patients with hyperlipidemia by administering alirocumab

The present invention provides methods for treating hypercholesterolemia. The methods of the present invention comprise administering to patients with heterozygous familial hypercholesterolemia a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P. The methods of the present invention are useful for treating patients with heterozygous familial hypercholesterolemia who are not adequately controlled by maximum tolerated dose statin therapy with or without other lipid lowering therapy.

Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody

The present invention relates to compositions and methods for altering body composition in a subject, wherein the alteration of body composition is an increase in muscle mass and a reduction of fat mass simultaneously. The present invention also relates to compositions and methods for reducing fat mass in a subject. The compositions and methods also increase muscle volume and lean body mass in the subject. The present invention also relates to compositions that comprise a GDF8 inhibitor and an Activin A inhibitor and the use of such compositions to treat diseases and disorders characterized by increased fat mass, and/or decreased muscle volume.

Methods for altering body composition by administering a GDF8 inhibitor and an Activin A inhibitor

Methods for increasing lean body mass with resistance training and a GDF8 inhibitor that is an anti-GDF8 antibody

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.

Dosing regimens for use with PCSK9 inhibitors

The present invention provides methods for reducing various lipoprotein fractions in the serum of patients. The methods of the invention include reducing serum remnant cholesterol, and/or the serum concentration of one or more LDL-C subfractions in a patient. The methods of the present invention comprise selecting a patient who exhibits elevated serum lipoproteins, and administering to the patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody such as the exemplary antibody referred to herein as mAb316P.

Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)

The present invention provides methods for treating hypercholesterolemia and reducing LDL-C. The methods of the present invention comprise administering to a subject in need thereof a therapeutic composition comprising an anti-PCSK9 antibody or antigen-binding fragment thereof.

Methods for treating hypercholesterolemia and reducing LDL-C using antibodies to PCSK9

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Ardsley, NY, United States of America

Robert C Pordy