Stabilized liquid and lyophilized ADAMTS13 formulations
AssigneeBaxalta Incorporated
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.
Claims30
A method of treating or preventing thrombotic thrombocytopenic purpura (TTP), the method comprising administering to a subject in need thereof a therapeutically effective dose of an ADAMTS13 formulation, wherein said subject is deficient in ADAMTS13 or suffers from hyperactive VWF and 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.