METHODS FOR TREATING PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (heFH) WITH AN ANTI-PCSK9 ANTIBODY

Abstract

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.

1 - 92 . (canceled) 
     
     
         93 . A method for treating hypercholesterolemia in a patient in need thereof having heterozygous familial hypercholesterolemia (heFH) and having a serum LDL-C concentration of greater than or equal to 70 mg/dL comprising administering, to the patient, a therapeutically effective amount of antibody or antigen-binding fragment thereof which specifically binds human PCSK9 and comprises an HCVR and an LCVR having the amino acid sequences of SEQ ID NOs: 1 and 6, respectively. 
     
     
         94 . The method of  claim 93 , wherein the patient has taken a daily dose of statin for at least 4 weeks. 
     
     
         95 . The method of  claim 94 , wherein the statin is cerivastatin, pitavastatin, fluvastatin, lovastatin and/or pravastatin. 
     
     
         97 . The method of  claim 93 , wherein the patient has a history of cardiovascular disease. 
     
     
         98 . The method of  claim 97 , wherein the cardiovascular disease is coronary heart disease, ischemic stroke or peripheral arterial disease. 
     
     
         99 . The method of  claim 93 , wherein said serum LDL-C is 100 mg/dL or more. 
     
     
         100 . The method of  claim 93 , wherein said serum LDL-C is 130 mg/dL or more. 
     
     
         101 . The method of  claim 93 , wherein said serum LDL-C is 140 mg/dL or more. 
     
     
         102 . The method of  claim 93 , wherein the antibody or fragment is administered subcutaneously. 
     
     
         103 . The method of  claim 93 , wherein the antibody or fragment is alirocumab.