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Summary for Patent: 9,539,263
|Title:||Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis|
|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), Jahreis; Angelika M. (Menlo Park, CA)|
|Assignee:||Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche, Inc. (Nutley, NJ) Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP)|
|Patent Claims:||1. A method of treating systemic sclerosis in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective
to treat the systemic sclerosis, wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose every week, and wherein the anti-IL-6R antibody comprises the light chain and heavy chain amino acid sequences of SEQ ID NOs. 1 and 2,
2. The method of claim 1 wherein the effective amount improves cutaneous sclerosis, improves physical function, and/or slows progression of organ damage, relative to placebo.
3. The method of claim 2 wherein cutaneous sclerosis improvement is assessed by modified Rodnan skin score (mRSS).
4. The method of claim 2 wherein physical function improvement is assessed by Scleroderma Health Assessment Questionnaire-Disability Index (HAQ-DI).
5. A method of treating systemic sclerosis in a patient comprising subcutaneously administering tocilizumab to the patient, wherein the tocilizumab is administered as a fixed dose of 162 mg per dose every week.
|Applicant||Tradename||Biologic Ingredient||Dosage Form||BLA||Number||Approval Date||Patent No.||Assignee||Estimated Patent Expiration||Status||Orphan||Source|
|Genentech||ACTEMRA||tocilizumab||INJECTABLE; INJECTION||125276||001||2010-01-08||Start Trial||Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche, Inc. (Nutley, NJ) Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP)||2030-11-08||RX||search|
|Genentech||ACTEMRA||tocilizumab||INJECTABLE; INJECTION||125276||002||2010-01-08||Start Trial||Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche, Inc. (Nutley, NJ) Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP)||2030-11-08||RX||search|
|Genentech||ACTEMRA||tocilizumab||INJECTABLE; INJECTION||125276||003||2010-01-08||Start Trial||2030-11-08||RX||search|
|Genentech||ACTEMRA||tocilizumab||INJECTABLE;INTRAVENOUS, SUBCUTANEOUS||125472||001||2013-10-21||Start Trial||2030-11-08||RX||search|
|>Applicant||>Tradename||>Biologic Ingredient||>Dosage Form||>BLA||>Number||>Approval Date||>Patent No.||>Assignee||>Estimated Patent Expiration||>Status||>Orphan||>Source|
|Country||Patent Number||Publication Date|
|World Intellectual Property Organization (WIPO)||2012064627||Jul 19, 2012|
|World Intellectual Property Organization (WIPO)||2012064627||May 18, 2012|
|United States of America||10231981||Mar 19, 2019|
|United States of America||2012301460||Nov 29, 2012|
|United States of America||2014056883||Feb 27, 2014|
|United States of America||2014056884||Feb 27, 2014|
|>Country||>Patent Number||>Publication Date|
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