Treatment of lupus nephritis using laquinimod

• US 8,889,661 B2
• Filed: 03/02/2011
• Issued: 11/18/2014
• Est. Priority Date: 03/03/2010
• Status: Expired due to Fees

• Current Assignee: Teva Pharmaceutical Industries Limited
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Haviv, Asi, Tarcic, Nora
• Primary Examiner(s): Sims, Jason
• Assistant Examiner(s): Bori, Ibrahim D
• Application Number:
  US13/039,178
• Publication Number:
  US 20110218179A1
• Time in Patent Office: 1,357 Days
• Field of Search: 514/171, 514/233.5, 514/312
• US Class Current: 514/171
• CPC Class Codes: A61K 2121/00 Preparations for use in therapy
• 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 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 31/4704 2-Quinolinones, e.g. carbostyril
• CPC Class Codes: A61K 31/5355 Non-condensed oxazines and containing further heterocyclic rings
• CPC Class Codes: A61K 31/5377 not condensed and containing further heterocyclic rings, e.g. timolol
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 36/47 Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 33/06 Antimalarials
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: C07D 215/22 attached in position 2 or 4

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.

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.