Research & Development
US Food and Drug Administration grants Sanofi approval for Cablivi
8 February 2019 -

The US Food and Drug Administration (FDA) has granted approval to France-based Sanofi for its blood-disorder drug Cablivi (caplacizumab-yhdp), it was reported yesterday.

The product has been approved in combination with plasma exchange and immunosuppression to treat acquired thrombotic thrombocytopenic purpura in adults. The product is said to be the first FDA-approved therapy for the treatment of acquired thrombotic thrombocytopenic purpura. It targets von Willebrand factor (vWF), a protein in the blood that involves in haemostasis. It has been designed to inhibit the interaction between vWF and platelets.

The product's approval was based on data from the Hercules multicentre, randomised, double-blind, placebo-controlled phase three clinical study. The company said that the treatment with Cablivi in combination with plasma exchange and immunosuppression resulted in a significantly shorter time to platelet count response against plasma exchange and immunosuppression alone, which is a primary efficacy endpoint.

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