Europe – Sanofi’s Cablivi cleared for rare bleeding disorder

Patients with the rare clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP) have gained a new treatment option in Europe with the approval of Sanofi’s Cablivi.

The European Commission has authorised Cablivi (caplacizumab) as the first therapeutic specifically indicated for the treatment of adults experiencing an episode of aTTP.

The condition is a life-threatening, autoimmune-based blood clotting disorder characterised by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count), microangiopathic hemolytic anemia (loss of red blood cells through destruction), ischemia and widespread organ damage.

Current standard-of-care is daily plasma exchange (PEX) and immunosuppression, but episodes of aTTP are still linked with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis, highlighting the need for new treatment options.

Patients with the rare clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP) have gained a new treatment option in Europe with the approval of Sanofi’s Cablivi.

The European Commission has authorised Cablivi (caplacizumab) as the first therapeutic specifically indicated for the treatment of adults experiencing an episode of aTTP.

The condition is a life-threatening, autoimmune-based blood clotting disorder characterised by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count), microangiopathic hemolytic anemia (loss of red blood cells through destruction), ischemia and widespread organ damage.

Current standard-of-care is daily plasma exchange (PEX) and immunosuppression, but episodes of aTTP are still linked with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis, highlighting the need for new treatment options…