Compositions comprising eicosapentaenoic acid and mipomersen and methods of use thereof

• US 9,624,492 B2
• Filed: 02/13/2014
• Issued: 04/18/2017
• Est. Priority Date: 02/13/2013
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Zakrzewski, Joseph S.
• Primary Examiner(s): ZARA, JANE J
• Application Number:
  US14/179,665
• Publication Number:
  US 20140243389A1
• Time in Patent Office: 1,160 Days
• Field of Search: 435 61, 435 911, 435 9, 435 131, 435455, 435 4, 435 58, 435 9131, 435458, 514 1, 514 2, 514 44, 536 231, 536 245, 424 91
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/7125 Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: C12N 15/113 Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing when used in plants C12N15/8218
• CPC Class Codes: C12N 2310/11 Antisense
• CPC Class Codes: C12N 2310/315 Phosphorothioates
• CPC Class Codes: C12N 2310/321 2'-O-R Modification
• CPC Class Codes: C12N 2310/3341 5-Methylcytosine
• CPC Class Codes: C12N 2310/341 Gapmers, i.e. of the type ===---===
• CPC Class Codes: C12N 2310/346 having a combination of backbone and sugar modifications
• CPC Class Codes: C12N 2310/3525 MOE, methoxyethoxy
• CPC Class Codes: C12N 2320/31 Combination therapy

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Claims

1. A method of treating cardiovascular disease in a subject, the method comprising administering to the subject a composition comprising mipomersen and a composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

2. The method of claim 1, wherein the method further comprises identifying the subject as having homozygous familial hypercholesterolemia (HoFH) before administering the composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

3. The method of claim 1, wherein the subject is on statin therapy.

4. The method of claim 1, wherein the composition comprising mipomersen and the composition comprising ethyl eicosapentaenoate are present in a single dosage form.

5. The method of claim 1, wherein the mipomersen is in a dosage form separate from the ethyl eicosapentaenoate.

6. A method of reducing triglycerides in a hypertriglyceridemic subject on mipomersen therapy, the method comprising administering to the subject a composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

7. The method of claim 6, wherein the ethyl eicosapentaenoate and the mipomersen are present in a single dosage form.

8. The method of claim 6, wherein the mipomersen is in a dosage form separate from the ethyl eicosapentaenoate.

9. The method of claim 6, wherein a cholesterol level is reduced in the subject compared to a second subject who has received the mipomersen but not the ethyl eicosapentaenoate.

10. The method of claim 9, wherein the cholesterol level is selected from the group consisting of:

HDL-C, LDL-C, non-HDL-C, VLDL-C, and combinations thereof.