Claims for Patent: 9,968,659

Summary for Patent: 9,968,659

Title:	Liraglutide in cardiovascular conditions
Abstract:	The present invention relates to the GLP-1 receptor agonist liraglutide for use in medicine.
Inventor(s):	Rasmussen; Soeren (Copenhagen, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	15/401,651
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,968,659
Patent Claims:	1. A method for reducing the development of a major adverse cardiovascular event (MACE), comprising administering liraglutide in a therapeutically effective amount to a subject in need thereof, wherein the subject has type 2 diabetes and cardiovascular disease, wherein the subject is not administered a dipeptidyl peptidase-4 inhibitor, and wherein the MACE is selected from the group consisting of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. 2. The method according to claim 1, wherein the subject is being administered cardiovascular medication. 3. The method according to claim 1, wherein the subject is .gtoreq.50 years of age. 4. The method according to claim 1, wherein the liraglutide is in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 5. The method according to claim 1, wherein the subject is .gtoreq.50 years of age, and wherein the liraglutide is in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 6. A method for reducing the development of a major adverse cardiovascular event (MACE), comprising administering a pharmaceutical composition to a subject in need thereof, wherein the subject has type 2 diabetes and cardiovascular disease, wherein the pharmaceutical composition consists essentially of liraglutide in a therapeutically effective amount and one or more excipients, and wherein the MACE is selected from the group consisting of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. 7. The method according to claim 6, wherein the subject is .gtoreq.50 years of age. 8. The method according to claim 6, wherein the liraglutide is administered in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 9. The method according to claim 6, wherein the subject is .gtoreq.50 years of age, and wherein the liraglutide is in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 10. The method according to claim 6, wherein the one or more excipients is selected from the group consisting of a buffer system, preservative, tonicity agent, chelating agent, stabilizer, and surfactant. 11. The method according to claim 6, wherein the pharmaceutical composition consists of about 6 mg/ml liraglutide, about 2-15 mM phosphate buffer, about 2-25 mg/ml propylene glycol, about 1-18 mg/ml phenol, and a pH in the range of 7.5-9.0. 12. The method according to claim 11, wherein the pharmaceutical composition consists of 6 mg/ml liraglutide, 1.42 mg/ml disodium phosphate dihydrate, 14.0 mg/ml propylene glycol, 5.5 mg/ml phenol, and a pH of 8.15. 13. A method for reducing the development of a major adverse cardiovascular event (MACE), comprising administering a pharmaceutical composition to a subject in need thereof, wherein the subject has type 2 diabetes and cardiovascular disease, wherein the pharmaceutical composition comprises liraglutide in a therapeutically effective amount and as the only active therapeutic ingredient, and wherein the MACE is selected from the group consisting of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. 14. The method according to claim 13, wherein the subject is .gtoreq.50 years of age. 15. The method according to claim 13, wherein the liraglutide is administered in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 16. The method according to claim 13, wherein the subject is .gtoreq.50 years of age, and wherein the liraglutide is in an amount selected from 0.6 mg, 1.2 mg, and 1.8 mg. 17. The method according to claim 13, wherein the concentration of liraglutide is about 6 mg/ml, and wherein the pharmaceutical composition further comprises about 2-15 mM phosphate buffer, about 2-25 mg/ml propylene glycol, about 1-18 mg/ml phenol, and a pH in the range of 7.5-9.0. 18. The method according to claim 13, wherein the concentration of liraglutide is 6 mg/ml, and wherein the pharmaceutical composition further comprises 1.42 mg/ml disodium phosphate dihydrate, 14.0 mg/ml propylene glycol, 5.5 mg/ml phenol, and a pH of 8.15.