Methods of reducing apolipoprotein C-III

• US 10,166,209 B2
• Filed: 12/23/2015
• Issued: 01/01/2019
• Est. Priority Date: 02/06/2013
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Manku, Mehar, Osterloh, Ian, Wicker, Pierre, Braeckman, Rene, Soni, Paresh, Zakrzewski, Joseph S.
• Primary Examiner(s): Tran, My-Chau T.
• Application Number:
  US14/757,773
• Publication Number:
  US 20160120837A1
• Time in Patent Office: 1,105 Days
• Field of Search: 514547, 514549
• CPC Class Codes: A61K 31/23 of acids having a carboxyl group bound to a chain of seven or more carbon atoms
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Claims

1. A method of reducing an apolipoprotein C-III (“

APOC3”

) level of a subject on statin therapy and having baseline fasting triglycerides of about 200 mg/dl to about 499 mg/dl, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate per day, wherein the APOC3 level is reduced by at least about 15%.

2. The method of claim 1, wherein about 2 g per day of ethyl eicosapentaenoate is administered to the subject.

3. The method of claim 1, wherein about 3.8 g to about 4 g per day of ethyl eicosapentaenoate is administered to the subject.

4. The method of claim 1, wherein the pharmaceutical composition is administered to the subject daily for a period of 1 to about 12 weeks.

5. The method of claim 1, wherein the reduction in APOC3 level is in comparison to control subjects having fasting triglycerides of about 200 mg/dl to about 499 mg/dl who have received the statin but not the pharmaceutical composition.

6. The method of claim 1, wherein the pharmaceutical composition comprises no more than about 10%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any.

7. The method of claim 1, wherein the pharmaceutical composition comprises no more than about 2%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any.