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Cablivi
Published
Product name
Cablivi
Active ingredient
Caplacizumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Cablivi (caplacizumab) was approved for the following therapeutic use:
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
How this medicine works
Caplacizumab is a humanised bivalent nanobody that consists of two identical humanised building blocks (PMP12A2hum1), genetically linked by a three-alanine linker, targeting the A1-domain of von Willebrand Factor and inhibiting the interaction between von Willebrand Factor and platelets. As such, caplacizumab prevents the ultralarge von Willebrand Factor-mediated platelet adhesion, which is characteristic of acquired thrombotic thrombocytopenic purpura (aTTP). It also affects the disposition of von Willebrand Factor, leading to transient reductions of total von Willebrand Factor antigen levels and to concomitant reduction of factor VIII:C levels during treatment.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Cablivi was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 318058