Laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients with a high disability status

• US 9,662,322 B2
• Filed: 11/19/2015
• Issued: 05/30/2017
• Est. Priority Date: 04/29/2014
• Status: Active Grant

• Current Assignee: Teva Pharmaceutical Industries Limited
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Knappertz, Volker
• Primary Examiner(s): Neagu, Irina
• Application Number:
  US14/946,586
• Publication Number:
  US 20160074378A1
• Time in Patent Office: 558 Days
• Field of Search: 514312, 546153, 546155, 544128
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 31/4704 2-Quinolinones, e.g. carbostyril
• CPC Class Codes: A61K 38/215 IFN-beta
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• 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 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

This invention provides a method for treating or for reducing ambulatory deterioration in a human patient diagnosed to be afflicted with relapsing-remitting multiple sclerosis (RRMS) and having a high baseline disability score according to the Kurtzke Expanded Disability Status Scale (EDSS), comprising periodically administering to only the patient diagnosed with RRMS and having a high baseline disability score an amount of laquinimod effective to treat the patient or to reduce ambulatory deterioration. This invention further provides pharmaceutical compositions and packages comprising an effective amount of laquinimod for treating a human patient diagnosed to be afflicted with RRMS and having a high baseline disability score according to the EDSS.

Claims

1. A method of reducing deterioration of ambulation of a human patient diagnosed to be afflicted with relapsing-remitting multiple sclerosis (RRMS) and to have a baseline disability score according to the Kurtzke Expanded Disability Status Scale (EDSS) of greater than 3, comprising periodically administering to only the patient diagnosed with RRMS and having a baseline EDSS score of greater than 3 an amount of laquinimod effective to reduce deterioration of the patient'"'"'s ambulation.

2. The method of claim 1, wherein the amount of laquinimod is effective to reduce the patient'"'"'s relapse rate.

3. The method of claim 1, wherein the amount of laquinimod is effective to reduce the patient'"'"'s accumulation of physical disability.

4. The method of claim 1, wherein ambulation is assessed by the patient'"'"'s Timed-25 foot walk test score.

5. The method of claim 1, wherein laquinimod is administered orally and/or daily.

6. The method of claim 1, wherein laquinimod is administered at a daily dose of 0.3 mg laquinimod.

7. The method of claim 1, wherein laquinimod is administered at a daily dose of 0.6 mg laquinimod.

8. The method of claim 1, wherein laquinimod is administered as adjunct therapy with another RRMS treatment.

9. The method of claim 8, wherein the other RRMS treatment is administration of interferon beta 1-a, interferon beta 1-b, glatiramer acetate, mitoxantrone or natalizumab.

16. The method of claim 1, wherein the patient has mobility impairment.

17. The method of claim 1, wherein the patient has a baseline EDSS score of 3.5-5.5.

18. The method of claim 1, wherein the laquinimod is laquinimod sodium.

19. The method of claim 16, wherein the mobility impairment is an ambulatory impairment.

20. The method of claim 19, wherein the patient is not ambulatory.

10. A method of reducing deterioration of ambulation of a human patient diagnosed to be afflicted with RRMS, worsening MS and to have a baseline disability score according to the Kurtzke Expanded Disability Status Scale (EDSS) of greater than 3.0, comprising periodically administering to only the patient diagnosed with RRMS, worsening MS and having an EDSS score of greater than 3.0 an amount of laquinimod effective to reduce deterioration of the patient'"'"'s ambulation.

11. The method of claim 10, wherein laquinimod is administered orally and/or daily.

12. The method of claim 10, wherein laquinimod is administered at a daily dose of 0.3 mg laquinimod.

13. The method of claim 10, wherein laquinimod is administered at a daily dose of 0.6 mg laquinimod.

14. The method of claim 10, wherein laquinimod is administered as adjunct therapy with another RRMS treatment.

15. The method of claim 14, wherein the other RRMS treatment is administration of interferon beta 1-a, interferon beta 1-b, glatiramer acetate, mitoxantrone or natalizumab.

21. The method of claim 10, wherein the amount of laquinimod is effective to reduce the patient'"'"'s relapse rate.

22. The method of claim 10, wherein the amount of laquinimod is effective to reduce the patient'"'"'s accumulation of physical disability.

23. The method of claim 10, wherein ambulation is assessed by the patient'"'"'s Timed-25 foot walk test score.

24. The method of claim 10, wherein the patient has a baseline EDSS score of 3.5-5.5.

25. The method of claim 10, wherein the laquinimod is laquinimod sodium.

26. The method of claim 10, wherein the patient has mobility impairment.

27. The method of claim 26, wherein the mobility impairment is an ambulatory impairment.

28. The method of claim 27, wherein the patient is not ambulatory.