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Biostate SP

Development stage: Unknown
Lead developer: CSL Behring
Modality: Recombinant Proteins and Enzymes
Administration: Intravenous

Overview

Biostate SP is a high-purity, plasma-derived concentrate of human von Willebrand factor (VWF) and coagulation factor VIII (FVIII), developed by CSL Behring. It is a specific formulation variant of the established product Biostate, characterized by a VWF:FVIII ratio of approximately 2.4:1 and the presence of high-molecular-weight VWF multimers. The 'SP' designation refers to a formulation evaluated in a Phase II clinical trial (NCT00879541) to assess its efficacy, safety, and pharmacokinetics in patients with haemophilia A. The drug acts as a replacement therapy, restoring the coagulation cascade by supplementing deficient levels of FVIII and VWF, thereby facilitating normal blood clotting in patients with haemophilia A or von Willebrand disease.

Brand names: BiostateVoncentoAleviate
Other names: Biostate SPVWF/FVIII concentrate

Targets

BB-031 (Von Willebrand factor)F8 (Coagulation Factor VIIIa)

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