FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi’s Treatment for Blood-Clotting Disorder Approved in Europe

Sept. 6, 2018

The European Commission granted Sanofi marketing authorization for Cablivi (caplacizumab), a treatment for adults suffering from a rare blood-clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP).

The medicine treats the autoimmune-based disorder that causes widespread clotting in small blood vessels throughout the body. It can result in extensive organ damage, especially in the brain and heart, and can lead to severe low platelet counts and loss of red blood cells.

The authorization comes after a June recommendation by the EMA’s Committee for Medicinal Products for Human Use in favor of the treatment, marking Sanofi’s first approval for a nanobody-based medicine.

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