Amarin's Epanova patent forwarded to examiner after affidavit's signed 9-10.
13/685,281
Should get NOA before Epanova's PDUFA
Let the games begin!!!
Here: 1. A method of lowering triglycerides in a subject with triglycerides of at least 500 mg/dl comprising, administering to the subject daily a pharmaceutical composition comprising an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg, and not more than about 30%, by weight of total fatty acids, docosahexaenoic acid, for a period effective to reduce triglycerides in the subject.
2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 10% in the subject.
3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 20% in the subject.
4. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C in the subject.
5. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C by 5% in the subject.
6. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C in the subject.
7. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C by 5% in the subject.
8. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1100 mg.
9. The method of claim 8 wherein administration of about 1100 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
10. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1650 mg.
11. The method of claim 10 wherein administration of about 1650 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
12. The method of claim 11 wherein the effective amount of eicosapentaenoic acid is about 2200 mg.
13. The method of claim 12 wherein administration of about 2200 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 400% in the subject.
14. The method of claim 13 wherein the pharmaceutical composition comprises not more than about 20%, by weight of total fatty acids, docosahexaenoic acid.
AI
