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Last Updated: January 29, 2022

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Claims for Patent: 9,889,179

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Summary for Patent: 9,889,179
Title:FGF-18 compound dosing regimen
Abstract: The present invention provides a new dosing regimen for administration of FGF-18 in the treatment of a cartilage disorder, such as osteoarthritis or cartilage injury. Specifically provided is a preferred treatment scheme comprising administrations every 3 weeks, 4 weeks or 5 weeks of an FGF-18 compound per treatment cycle. The new dosing regimen can include the co-adminsitration of an anti-inflammatory drug.
Inventor(s): Ladel; Christoph H. (Darmstadt, DE), Guehring; Hans (Eltville, DE)
Assignee: MERCK PATENT GMBH (Darmstadt, DE)
Application Number:15/120,131
Patent Claims:1. A method for the treatment of a cartilage disorder comprising administering to a subject having a cartilage disorder an FGF-18 compound selected from the group consisting of: a polypeptide comprising residues 28-207 of SEQ ID NO:1; and a polypeptide comprising SEQ ID NO:2, wherein said FGF-18 compound is administered at least twice per treatment cycle, said administrations being separated by about at least 3, 4 or 5 weeks.

2. The method according to claim 1, wherein said administrations are separated by about 3 weeks or by about 4 weeks.

3. The method according to claim 1, wherein said administrations are separated by about 1 month.

4. The method according to claim 1, wherein the FGF-18 compound is administered at least 3 times or at least 4 times per treatment cycle.

5. The method according to claim 1, wherein treatment cycles are repeated after 2, 3, 4, 5 or 6 months.

6. The method according to claim 1, which comprises 1, 2 or 3 treatment cycles per year.

7. The method according to claim 1, wherein the FGF-18 compound is administered intra-articularly.

8. The method according to claim 1, wherein the FGF-18 compound is administered at a dose of 3-300 mcg per single intra-articular administration.

9. The method according to claim 8, wherein the FGF-18 compound is to be administered at a dose selected from about 3, 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, 200, 240 or 300 mcg per single intra-articular administration of the FGF-18 compound.

10. The method according to claim 1, wherein the cartilage is articular cartilage.

11. The method according to claim 1, wherein the cartilage disorder is osteoarthritis.

12. The method according to claim 1, wherein the cartilage disorder is cartilage injury.

13. The method according to claim 1, wherein the FGF-18 compound is a polypeptide comprising residues 28-207 of SEQ ID NO:1.

14. The method according to claim 1, wherein the FGF-18 compound is administered together with an anti-inflammatory drug.

15. The method according to claim 14, wherein the anti-inflammatory drug is anakinra or diclofenac.

16. The method according to claim 14, wherein the anti-inflammatory drug is administered at a dose of 0.001-500 mg per single administration.

17. The method according to claim 16, wherein the anti-inflammatory drug is administered at a dose selected from 0.03, 0.1, 0.25, 0.3, 0.5, 1, 1.5, 2, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 250 or 300 mg per single administration.

18. The method according to claim 1, wherein the FGF-18 compound is administered 3 times per treatment cycle, said administrations being separated by about 3 weeks.

19. The method according to claim 1, wherein the FGF-18 compound is administered 3 times per treatment cycle, said administrations being separated by about 4 weeks.

20. The method according to claim 1, wherein the FGF-18 compound is administered once monthly for 3 consecutive months.

21. The method according to claim 1, wherein the FGF-18 compound is a polypeptide comprising SEQ ID NO:2.

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