Tags : Cablivi

Sanofi’s Cablivi (caplacizumab-yhdp) Receives FDA’s Approval for Acquired Thrombotic Thrombocytopenic

Shots: The approval is based on P-III HERCULES study results assessing Cablivi + plasma exchange and immunosuppressive therapy vs PBO (plasma exchange and immunosuppressive therapy) in 145 adults with aTTP P-III study results: reduction on a composite endpoint of aTTP-related death (12.7% vs 49.3%); aTTP recurrences (13% vs 38%); no deaths reported Cablivi (caplacizumab-yhdp) is […]Read More

Sanofi Reports Results of Cablivi (caplacizumab) in P-III HERCULES Study

Shots: The P-III HERCULES study involves assessing Cablivi vs PBO in 145 patients with acquired thrombotic thrombocytopenic purpura (aTTP) in plasma exchange & immunosuppression P-III HERCULES study results: achievement in normal platelet count (1.55 times); reduction in death/recurrence of aTTP (74%); reduction in aTTP recurrence (67%); refractory disease developed (0 vs 3); normalization in three […]Read More

Sanofi’s Cablivi Receives EU Marketing Approval for the Treatment of

Shots: The approval is based on P-II TITAN and P-III HERCULES studies enrolling 220 adults assessing Cablivi (caplacizumab) vs PBO, testing its safety and efficacy P-III HERCULES results:  significantly shorter time to platelet count response, reduction in aTTP-related death, lower number of aTTPrecurrence, meaningful reduction in use of plasma exchange (PEX) compared to PBO Cablivi […]Read More