Caplacizumab


Caplacizumab, sold under the brand name Cablivi, is a monoclonal antibody used for the treatment of thrombotic thrombocytopenic purpura. It is a von Willebrand factor-directed antibody fragment. It is given via intravenous injection followed by subcutaneous injection. Caplacizumab was developed by Ablynx NV.
Caplacizumab was authorized for medical use in the European Union in August 2018, and approved for medical use in the United States in February 2019. The US Food and Drug Administration considers it to be a first-in-class medication.

Medical uses

Caplacizumab is indicated for the treatment of acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy.

Side effects

Common adverse effects include injection site reactions, reported in 3–6% of patients in the HERCULES and TITAN trials.

Society and culture

Legal status

Caplacizumab was authorized for medical use in the European Union in August 2018, and approved for medical use in the United States in February 2019.

Economics

The cost-effectiveness has been questioned.

Names

Caplacizumab is the international [nonproprietary name] and the United States Adopted Name.

Research

Use of caplacizumab without plasmapheresis has been reported. The MAYARI study was designed to evaluate the effectiveness of this option.