Claims for Patent: 9,750,752

Summary for Patent: 9,750,752

Title:	Subcutaneously administered anti-IL-6 receptor antibody
Abstract:	The present application discloses methods for treating an IL-6-mediated disorder such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), systemic JIA (sJIA), polyarticular course JIA (pcJIA), systemic sclerosis, or giant cell arteritis (GCA), with subcutaneously administered antibody that binds interleukin-6 receptor (anti-IL-6R antibody). In particular, it relates to identification of a fixed dose of anti-IL-6R antibody, e.g. tocilizumab, which is safe and effective for subcutaneous administration in patients with IL-6-mediated disorders. In addition, formulations and devices useful for subcutaneous administration of an anti-IL-6R antibody are disclosed.
Inventor(s):	Zhang; Xiaoping (Wayne, NJ), Terao; Kimio (Funabashi, JP), Harari; Olivier Alfred (London, GB)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ) Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP)
Application Number:	14/062,026
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,750,752
Patent Claims:	1. A method of treating giant cell arteritis (GCA) in a patient comprising administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective to treat the GCA, wherein the anti-IL-6R antibody is administered subcutaneously as a fixed dose of 162 mg per dose every week or every two weeks, and wherein the anti-IL-6R antibody comprises the light chain and heavy chain amino acid sequences of SEQ ID NOs. 1 and 2, respectively. 2. The method of claim 1 wherein the fixed dose is administered every week. 3. The method of claim 1 wherein the fixed dose is administered every two weeks. 4. The method of claim 1 further comprising administering an initial course of corticosteroid to the patient. 5. The method of claim 1 wherein the effective amount reduces GCA signs and symptoms, maintains clinical remission, and/or reduces or stops corticosteroid to be administered to the patient. 6. The method of claim 1 wherein the GCA is new onset GCA. 7. The method of claim 1 wherein the GCA is refractory GCA. 8. A method of treating giant cell arteritis in a patient comprising administering tocilizumab to the patient, wherein the tocilizumab is administered subcutaneously as a fixed dose of 162 mg per dose every week or every two weeks. 9. The method of claim 8 wherein the fixed dose is administered every week. 10. The method of claim 8 wherein the fixed dose is administered every two weeks. 11. The method of claim 8 further comprising administering an initial course of corticosteroid to the patient. 12. The method of claim 8 wherein the treatment reduces giant cell arteritis signs and symptoms in the patient. 13. The method of claim 8 wherein the treatment maintains clinical remission in the patient. 14. The method of claim 8 wherein the treatment reduces or stops corticosteroid to be administered to the patient. 15. The method of claim 8 wherein the giant cell arteritis (GCA) is new onset GCA. 16. The method of claim 8 wherein the giant cell arteritis (GCA) is refractory GCA.

Details for Patent 9,750,752

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125276	01/08/2010		2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	10/21/2013		2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	11/19/2018		2030-11-08