Claims for Patent: 8,454,965

Summary for Patent: 8,454,965

Title:	Method for the treatment of multiple sclerosis
Abstract:	A method for treating a subject with multiple sclerosis is disclosed herein. In one embodiment, a method is provided for treating a subject with multiple sclerosis that includes administering to the subject a therapeutically effective amount of an IL-21 receptor antagonist, wherein the subject has failed to respond treatment with beta interferon, thereby treating the subject.
Inventor(s):	Martin; Roland (Hamburg, DE), McFarland; Henry (Gaithersburg, MD), Bielekova; Bibiana (Kensington, MD)
Assignee:	The United States of America as represented by The Secretary of the Department of Health and Human Services (Washington, DC) N/A (N/A)
Application Number:	11/827,876
Patent Claims:	1. A method of treating a human subject suffering from relapsing remitting multiple sclerosis, comprising administering daclizumab monthly to the subject in a unit dose ranging from about 150 mg to about 400 mg, wherein the subject is not concurrently treated with interferon-.beta.. 2. The method of claim 1, wherein the daclizumab is administered for a year. 3. The method of claim 1, wherein the daclizumab is administered indefinitely. 4. The method of claim 1, wherein the daclizumab is formulated as a solution containing from 1 wt % to 15 wt % or 20 wt % daclizumab. 5. The method of claim 1, wherein the daclizumab is administered is administered as monotherapy. 6. The method of claim 1, wherein the daclizumab is administered in an amount effective to reduce the rate of increase of the subject's disability score. 7. A method of treating a human subject suffering from relapsing remitting multiple sclerosis, comprising administering monthly to the subject a humanized monoclonal antibody that specifically binds the alpha subunit of the interleukin-2 receptor in a dose ranging from about 150 mg to about 400 mg, wherein the subject is not concurrently treated with interferon-.beta., and wherein the antibody comprises: (a) a V.sub.H chain having the amino acid sequence: QVQLVQSGAE VKKPGSSVKV SCKASGYTFT SYRMHWVRQ APGQGLEWIG YINPSTGYTEY NQKFKDKATI TADESTNTAY MELSSLRSED TAVYYCARGG GVFDYWGQG TLVTVSS (SEQ ID NO: 1); and (b) a V.sub.L chain having the amino acid sequence: DIQMTQSPS TLSASVGDR VTITCSASSS ISYMHWYQ QKPGKAPK LLIYTTSNLAS GVPARFSG SGSGTEFTLT ISSLQPDDF ATYYCHQRS TYPLTFGQG TKVEVK (SEQ ID NO: 2). 8. The method of claim 7, wherein the humanized monoclonal antibody is administered for a year. 9. The method of claim 7, wherein the humanized monoclonal antibody is administered indefinitely. 10. The method of claim 7, wherein the humanized monoclonal antibody is formulated as a solution containing from 1 wt % to 15 wt % or 20 wt % antibody. 11. The method of claim 7, wherein the humanized monoclonal antibody is administered in a unit dosage form containing 150 mg antibody. 12. The method of claim 7, wherein the humanized monoclonal antibody is administered in a unit dosage form containing 200 mg antibody. 13. The method of claim 7, wherein the humanized monoclonal antibody is administered as monotherapy. 14. The method of claim 7, wherein the humanized monoclonal antibody is administered in an amount effective to decrease the number of contrast enhancing-lesions in the subject as evaluated by Magnetic Resonance Imaging. 15. The method of claim 7, wherein the humanized monoclonal antibody is administered in an amount effective to reduce the rate of increase of the subject's disability score.

Details for Patent 8,454,965

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2022-06-28
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2022-06-28
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2022-06-28