FDA approves Cablivi to treat acquired thrombotic thrombocytopenic purpura .-Ablynx/Sanofi

The FDA has approved Cablivi (caplacizumab-yhdp) from Ablynx/Sanofi in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. Cablivi targets von Willebrand factor (vWF), a protein in the blood involved in hemostasis. It is designed to inhibit the interaction between vWF and platelets. Cablivi is an anti-vWF Nanobody and Sanofi�s first Nanobody -based medicine to receive approval in the U.S. Nanobodies are a novel class of proprietary therapeutic proteins based on single-domain antibody fragments that contain the unique structural and functional properties of naturally occurring heavy chain only antibodies. Cablivi received FDA Fast Track designation and was evaluated under Priority Review, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions.