European Commission approves Sanofi nanoantibody drug Cablivi for treatment of adult patients with aTTP
Last Update: 2020-06-11
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aTTP is a life-threatening, autoimmune-based clotting disorder characterized by the formation of large numbers of blood clots in small blood vessels throughout the body, leading to severe thrombocytopenia (very low thrombocytopenia), microvascular lesions hemolytic anemia (loss of red blood cells due to hemolytic damage), tissue ischemia (part of the body's bloodsupply(limited) and extensive organ damage, especially in the brain and heartrecently, France'sPharmaceutical, the giant Sanofi nanoantibodydrug, has been in good news on EU regulationThe European Commission (EC) has approved the drug for the treatment of adult patients with acquired thrombosis reduced cyanosis (aTTP)approval, making Cablivi the world's first approved nanoantibody drug and the first drug specifically designed to treat aTTPin the U.S., Cablivi has been granted fast-track status and is currentlythe FDA(which is being reviewed first and will make a final review decision on February 6, 2019)about Cablivi
Cablivi's active pharmaceutical ingredient is caplacizumab, a powerful selective bivalent anti-amodophilia factor (vWF) nanoantibody that was granted orphan status in the United States and the European Union in 2009Caplacizumab blocks the interaction of super-large vWF polypolymers (ULvWF) with platelets, so the formation and accumulation of tiny blood clots (microclots) that occur immediately for platelet aggregation and subsequent occurrencein patients with aTTP, this tiny blood clot can lead to severe thrombocyta, tissue ischemia, and organ dysfunctionThis instantaneous effect of the drug (immediate effect, i.e instant effect) can also protect patients with aTTP from clinical manifestations of the disease while dismantling the process of underlying disease related studies
Cablivi was approved based on data from a Phase II clinical study, TITAN and a Phase III clinical study These studies, which enrolled a total of 220 aTTP adult patients, confirmed the efficacy and safety of Cablivi's combined standard care regimen (once pex and immunosuppressive therapy) in treating aTTP In the Phase III study HERCULES, cablivi's combined standard care program significantly shortened the platelet count response time (p0.01) to the main endpoint of the study compared to the placebo-plus standard care regimen in addition, , cablivi's joint standard care program significantly reduced aTTP-related death, aTTP recurrence, or at least one major thrombosis event (p0.0001) during the study period, and significantly reduced the number of aTTP recurrences (p 0.001) throughout the study period Importantly, compared to placebo, the use of Cablivi treatment resulted in a reduction in the use of PEX, the length of intensive care unit (ICU) hospitalization, and the length of hospital stay safety
Cablivi has shown safety in clinical studies that are consistent with its mechanism of action The most common adverse reactions are nosebleeds, headaches and bleeding gums In both studies, no deaths were reported in the Cablivi treatment group during the drug treatment, while two deaths were reported in the placebo group in both studies
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