Sanofi Reports Results of Cablivi (caplacizumab) in P-III HERCULES Study in Patients with Rare Blood Clotting Disorder, Published in NEJM
Sanofi Reports Results of Cablivi (caplacizumab) in P-III HERCULES Study in Patients with Rare Blood Clotting Disorder, Published in NEJM
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 organ-damage markers sooner; plasma exchange reduction(5.8 days,38% vs 9.4 days); reduction of staying days in ICU/hospitals (65%/31%)
- Cablivi (caplacizumab) is an anti-vWF (von Willebrand Factor) further blocking interaction b/w ultra-large vWF multimersand platelets approved by EU in Aug, 2018 for aTTP in adults. Additionally, FDA
has accepted its priority review for BLA with expected PDUFA 6 Feb, 2019
Click here to read full press release/ article | Ref: Sanofi | Image: EMBL-EBI