US 12,419,937 B2
High concentration alpha-glucosidase compositions for the treatment of Pompe disease
Kenneth Valenzano, East Brunswick, NJ (US); John Crowley, Princeton, NJ (US); Richie Khanna, Somerset, NJ (US); and John Flanagan, East Windsor, NJ (US)
Assigned to Amicus Therapeutics, Inc., Philadelphia, PA (US)
Filed by Amicus Therapeutics, Inc., Philadelphia, PA (US)
Filed on Mar. 21, 2022, as Appl. No. 17/699,910.
Application 16/015,556 is a division of application No. 15/192,137, filed on Jun. 24, 2016, granted, now 10,046,033, issued on Aug. 14, 2018.
Application 17/699,910 is a continuation of application No. 16/580,541, filed on Sep. 24, 2019, granted, now 11,278,599.
Application 16/580,541 is a continuation of application No. 16/015,556, filed on Jun. 22, 2018, granted, now 10,512,677, issued on Apr. 19, 2022.
Application 15/192,137 is a continuation of application No. 14/379,131, granted, now 9,404,100, issued on Aug. 2, 2016, previously published as PCT/US2013/029660, filed on Mar. 7, 2013.
Claims priority of provisional application 61/750,718, filed on Jan. 9, 2013.
Claims priority of provisional application 61/607,920, filed on Mar. 7, 2012.
Prior Publication US 2022/0347272 A1, Nov. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/47 (2006.01); A61K 9/00 (2006.01); A61K 31/445 (2006.01); A61K 31/7008 (2006.01); A61K 47/22 (2006.01); C12N 9/26 (2006.01); C12N 9/96 (2006.01)
CPC A61K 38/47 (2013.01) [A61K 9/0019 (2013.01); A61K 31/445 (2013.01); A61K 31/7008 (2013.01); A61K 47/22 (2013.01); C12N 9/2408 (2013.01); C12N 9/96 (2013.01); C12Y 302/0102 (2013.01)] 18 Claims
 
1. A method of treating Pompe disease in a subject comprising administering
(i) a first composition comprising n-butyl-deoxynojirimycin or a pharmaceutically acceptable salt thereof, and
(ii) a second composition comprising acid α-glucosidase, wherein the acid α-glucosidase is formulated at a concentration of about 5 mg/ml to about 80 mg/mL in the second composition, and
wherein the n-butyl-deoxynojirimycin and the acid α-glucosidase is administered in an amount effective for treating Pompe disease in the subject.