European regulators have issued a green light for Bio Products Laboratory’s Coagadex, marking the first-ever treatment for the rare bleeding disorder factor X deficiency.
The European Medicines Agency has cleared Coagadex for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.
Factor X deficiency is a rare and serious condition caused by a lack of the protein Factor X, which plays a crucial role in coagulation. The condition, which affects around 700 people in the region, leaves patients at increased risk of bleeding or excessive or prolonged bleeding.
“Until now, we have focused on treating Factor X deficiency with blood infusions of plasma or a concentrate of clotting factors. We have wanted a specific Factor X therapy to treat these vulnerable patients. Therefore, the approval of Coagadex in the EU today is a significant advance for patients,” said Flora Peyvandi, director of Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre.