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Summary for Patent: 9,676,860
|Title:||DAC HYP compositions and methods|
|Abstract:||The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.|
|Inventor(s):||Hartman; Taymar E. (Redwood City, CA), Sauer; Paul W. (Fremont, CA), Burky; John E. (Newark, CA), Wesson; Mark C. (San Ramon, CA), Huang; Ping Y. (Fremont, CA), Robinson; Thomas J. (San Mateo, CA), Partridge; Braeden D. (Sunnyvale, CA), Tso; J. Yun (Menlo Park, CA)|
|Assignee:||AbbVie Biotherapeutics Inc. (Redwood City, CA)|
|Patent Claims:||1. A method of treating a patient suffering from multiple sclerosis, comprising administering to the patient an amount of a daclizumab composition sufficient to provide
therapeutic benefit, wherein the daclizumab has two or more of the following: (a) an N-terminal isoform with one pyroglutamate residue and one glutamine residue that comprises 3%-17% of the total daclizumab: (b) an N-linked oligosaccharide profile
comprising two main peaks and a minor peak, wherein one of the two main peaks is GO-GlcNAc glycoform present in about 5% to about 20% of the AUC, the other main peak is GO glycoform present in about 70% to about 99.2% of the AUC, and the minor peak is G1
glycoform present in 1% to 9% of the AUC when determined according to the method described in Section 7.6.14, (c) <3% aggregates when formulated at a concentration of about 150 mg/mL.
2. The method of claim 1 in which the daclizumab composition is administered: (a) subcutaneously; (b) in an amount corresponding to about 1 mg/kg daclizumab, once every two weeks or in an amount corresponding to about 2 mg/kg daclizumab, once every month; (c) for a total of about 24 weeks; or (d) according to any combination of (a)-(c).
3. The method of claim 2, in which the daclizumab composition is administered in an amount corresponding to 75 mg to 300 mg daclizumab, or 150 mg, or 300 mg.
4. The method of claim 3 wherein the daclizumab composition is administered subcutaneously in an amount corresponding to 150 mg daclizumab once every month.
5. The method of claim 3 in which the daclizumab is administered as monotherapy, in which the patient has either failed to respond to prior treatment with interferon-beta or has discontinued prior treatment with interferon-beta.
6. The method of claim 3 in which the daclizumab is administered adjunctively to interferon-beta.
7. The method of claim 1 in which the daclizumab has an N-linked glycosylation profile determined according to the method described in Section 7.6.14, in which the total AUC of the peaks in the profile corresponding to non-fucosylated mannose glycosyls is less than about 6% of the total AUC of all peaks in the profile.
8. The method of claim 4 which is administered for a total of at least 48 weeks.
|Applicant||Tradename||Biologic Ingredient||Dosage Form||BLA||Approval Date||Patent No.||Expiredate|
|Hoffmann-la Roche Inc.||ZENAPAX||daclizumab||Injection||103749||1997-12-10||⤷ Sign up for a Free Trial||2031-05-27|
|Biogen Inc.||ZINBRYTA||daclizumab||Injection||761029||2016-05-27||⤷ Sign up for a Free Trial||2031-05-27|
|Biogen Inc.||ZINBRYTA||daclizumab||Injection||761029||2017-05-26||⤷ Sign up for a Free Trial||2031-05-27|
|>Applicant||>Tradename||>Biologic Ingredient||>Dosage Form||>BLA||>Approval Date||>Patent No.||>Expiredate|
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