Sanofi's Cablivi Receives EU Marketing Approval for the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
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 was designated with Orphan Drug in EU and the US in 2009- in Switzerland and Japan in 2017 and 2018 respectively- additionally FDA has accepted priority review BLA with target action date 6 Feb- 2019
Ref: Sanofi | Image: Sanofi
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