FDA grants approval of crizanlizumab-tmca (Adakveo) to reduce frequency of vaso-occlusive crisis in sickle cell disease

Source:
US Food and Drug Administration - FDA
Publisher:
US Food and Drug Administration
Publication date:
16 November 2019

Abstract

Approval based on results of 52-week SUSTAIN RCT (n=198) which showed that crizanlizumab-tmca significantly lowered median annual rate of vaso-occlusive crises vs placebo (1.63 vs 2.98; P=.010). Reductions were observed regardless of disease genotype and/or hydroxyurea use.