Stabilized liquid and lyophilized ADAMTS13 formulations
AssigneeTakeda Pharmaceutical Company Limited
InventorsPeter Matthiessen, Peter L. Turecek, Hans-Peter Schwarz
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Abstract
The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.
Claims20
A method of treating or preventing myocardial infarction, the method comprising administering to a subject in need thereof a therapeutically effective dose of an ADAMTS13 formulation, wherein said formulation comprises:
- (a) 0.05 mg/ml to 10.0 mg/ml ADAMTS13;
- (b) 0 mM to 100 mM of a pharmaceutically acceptable salt
- (c) 0.5 mM to 20 mM calcium;
- (d) a sugar and/or sugar alcohol;
- (e) a nonionic surfactant;
- and
- (f) a buffering agent for maintaining a pH between 6.0 and 8.0.
A method of treating or preventing pulmonary embolism, the method comprising administering to a subject in need thereof a therapeutically effective dose of an ADAMTS13 formulation, wherein said formulation comprises:
- (a) 0.05 mg/ml to 10.0 mg/ml ADAMTS13;
- (b) 0 mM to 100 mM of a pharmaceutically acceptable salt
- (c) 0.5 mM to 20 mM calcium;
- (d) a sugar and/or sugar alcohol;
- (e) a nonionic surfactant;
- and
- (f) a buffering agent for maintaining a pH between 6.0 and 8.0.
Dependencies are inferred from the claim text.