Posted by Michael Wonder on 03 Sep 2018
Cablivi (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura
3 September 2018 - In addition, U.S. FDA to conduct priority review of caplacizumab with a target action date of 6 February 2019.
The European Commission has granted marketing authorization for Cablivi (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder. Cablivi is the first therapeutic specifically indicated for the treatment of aTTP.
The approval of Cablivi in the EU is based on the Phase II TITAN and Phase III HERCULES studies in 220 adult patients with aTTP. The efficacy and safety of caplacizumab in addition to standard-of-care treatment, daily PEX and immunosuppression, were demonstrated in these studies.
