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
Ref: Sanofi | Image: EMBL-EBI
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