Claims for Patent: 8,889,661

Summary for Patent: 8,889,661

Title:	Treatment of lupus nephritis using laquinimod
Abstract:	This invention provides a method of treating a subject afflicted with active lupus nephritis comprising periodically administering to the subject an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the subject. This invention also provides laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with active lupus nephritis. This invention further provides a pharmaceutical composition comprising an amount of laquinimod or pharmaceutically acceptable salt thereof for use in treating a subject afflicted with active lupus nephritis.
Inventor(s):	Haviv; Asi (Kvutsat Shiller, IL), Tarcic; Nora (Modiin, IL)
Assignee:	Teva Pharmaceutical Industries, Ltd. (Petach-Tikva, IL)
Application Number:	13/039,178
Patent Claims:	1. A method of treating a subject afflicted with active lupus nephritis comprising administering to the subject daily between 0.5-1.0 mg of laquinimod or pharmaceutically acceptable salt thereof and between 1-3 g of mycophenolate mofetil, wherein the amount of laquinimod and the amount of mycophenolate mofetil when taken together are more effective to treat he subject than when each agent is administered alone. 2. The method of claim 1, wherein the pharmaceutically acceptable salt of laquinimod is laquinimod sodium. 3. The method of claim 1, wherein the daily administration laquinimod or pharmaceutically acceptable salt thereof is effected orally. 4. The method of claim 1, wherein the amount of laquinimod administered is 0.5 mg/day. 5. The method of claim 1, wherein the amount of laquinimod administered is 1.0 mg/day. 6. The method of claim 1, wherein the daily administration of mycophenolate mofetil is effected orally. 7. The method of claim 1, wherein the amount of mycophenolate mofetil administered is 2 g/day. 8. The method of claim 1, further comprising administering to the subject an amount of a steroid. 9. The method of claim 8, wherein the administration of the steroid is daily administration. 10. The method of claim 8, wherein the administration of the steroid is effected orally and/or intravenously. 11. The method of claim 8, wherein the amount of steroid administered is 500 mg/day methylprednisolone. 12. The method of claim 8, wherein the amount of steroid administered is 40 mg/day prednisolone and/or prednisone. 13. The method of claim 1, further comprising administration of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), antimalarials, statins, cyclophosphamide, azathioprine, 6-mercaptopurine, abatacept, rituximab, belimumab, cyclosporine or other calcineurin inhibitors. 14. The method of claim 1, wherein the daily administration continues for at least 24 weeks. 15. The method of claim 1, wherein the subject is human.

Details for Patent 8,889,661

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2030-03-03
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2030-03-03
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118	12/23/2005		2030-03-03
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	07/29/2011		2030-03-03
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	06/07/2016		2030-03-03
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	03/30/2017		2030-03-03