US 9,809,652 B2
Methods of treating progressive forms of multiple sclerosis comprising subcutaneously administering daclizumab
Steven Jay Greenberg, Pawleys Island, SC (US); and Jacob Stephen Broomall Elkins, Brookline, MA (US)
Assigned to AbbVie Biotherapeutics Inc., Redwood City, CA (US); and Biogen MA Inc., Cambridge, MA (US)
Appl. No. 14/236,374
Filed by Steven Jay Greenberg, Pawleys Island, SC (US); and Jacob Stephen Broomall Elkins, Brookline, MA (US)
PCT Filed Aug. 8, 2012, PCT No. PCT/US2012/049995
§ 371(c)(1), (2), (4) Date Aug. 20, 2014,
PCT Pub. No. WO2013/022972, PCT Pub. Date Feb. 14, 2013.
Claims priority of provisional application 61/521,338, filed on Aug. 8, 2011.
Claims priority of provisional application 61/521,343, filed on Aug. 8, 2011.
Prior Publication US 2014/0356351 A1, Dec. 4, 2014
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/2866 (2013.01) [A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/24 (2013.01); C07K 2317/732 (2013.01); C07K 2317/92 (2013.01); C07K 2317/94 (2013.01)] 5 Claims
 
1. A method of treating a human subject suffering from a progressive form of multiple sclerosis, comprising subcutaneously administering to the subject about 150 mg to about 300 mg of a daclizumab once every four weeks for a period of at least one year,
wherein the daclizumab has one or both of the following:
(a) an N-terminal isoform with one glutamine residue and one valine residue that comprises 3%-12% 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 G0-GlcNAc glycoform present in 7% to 15% of the AUC, the other main peak is G0 glycoform present in 81% to 88% of the AUC, and the minor peak is G1 glycoform present in 1% to 4% of the AUC when determined according to the method described in Section 7.6.14.