Posted by Michael Wonder on 02 Jul 2018
CHMP recommends approval of Cablivi (caplacizumab)
29 June 2018 - First therapeutic to receive positive CHMP opinion for treatment of a rare blood disorder called acquired thrombotic thrombocytopenic purpura.
The European Medicines Agency’s CHMP has recommended approval of Cablivi (caplacizumab) in Europe for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder. Cablivi was developed by Ablynx, a Sanofi Company.
The potential of Cablivi to address this unmet need has been demonstrated in 220 patients with aTTP, who participated in the phase II TITAN and phase III HERCULES studies. Data from the TITAN study were published in the New England Journal of Medicine in February 2016 and the positive HERCULES results were presented at the 59th Annual Meeting of the American Society of Hematology in December 2017.
