US 12,030,925 B2
Methods of treating hemophilia A
Ekta Seth Chhabra, Framingham, MA (US); Alison Innes, Waltham, MA (US); Dan Rudin, Waltham, MA (US); Kara Rice, Waltham, MA (US); Nancy Wong, Waltham, MA (US); and Suresh Katragadda, Waltham, MA (US)
Assigned to BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed by BIOVERATIV THERAPEUTICS INC., Waltham, MA (US)
Filed on May 17, 2019, as Appl. No. 16/415,893.
Claims priority of provisional application 62/801,576, filed on Feb. 5, 2019.
Claims priority of provisional application 62/773,785, filed on Nov. 30, 2018.
Claims priority of provisional application 62/712,880, filed on Jul. 31, 2018.
Claims priority of provisional application 62/673,670, filed on May 18, 2018.
Prior Publication US 2019/0375822 A1, Dec. 12, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/00 (2006.01); A61P 7/04 (2006.01); C07K 14/755 (2006.01)
CPC C07K 14/755 (2013.01) [A61P 7/04 (2018.01); A61K 38/00 (2013.01); C07K 2319/30 (2013.01)] 19 Claims
 
1. A method of treating hemophilia A comprising administering multiple doses of a chimeric polypeptide at a dosing interval to a human subject in need thereof, wherein the chimeric polypeptide comprises:
(i) a FVIII protein comprising the amino acid sequence of SEQ ID NO: 207; and
(ii) a VWF protein comprising the amino acid sequence of SEQ ID NO: 202;
wherein each of the multiple doses is from 45 IU/kg to 55 IU/kg and the dosing interval is at least 6 days to 8 days; and
wherein the multiple doses are administered for at least about 6 months;
wherein the chimeric polypeptide is administered for prophylactic treatment;
wherein the subject has less than 1 IU/dL endogenous FVIII;
wherein the subject is at least 12 years of age;
wherein the FVIII protein is covalently linked to the VWF protein by a disulfide bond, and
wherein the chimeric polypeptide is administered intravenously.