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Last Updated: October 21, 2019

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Claims for Patent: 9,539,263

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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)
Application Number:14/062,005
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, respectively.

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.

Details for Patent 9,539,263

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 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;INTRAVENOUS, SUBCUTANEOUS 125472 001 2013-10-21   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
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

International Patent Family for US Patent 9,539,263

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