FDA approves Adakveo® (crizanlizumab) to reduce frequency of pain crises in sickle cell disease
The U.S. Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab) 5 mg/kg to reduce frequency of vaso-occlusive crises (VOC) in people with sickle cell disease. Crizanlizumab, previously known as SEG101, was developed by Novartis.
The FDA approval’s decision is based on results of SUSTAIN study. SUSTAIN is a randomized, placebo-controlled trial conducted over 52 weeks. It showed that the median annual rate of VOCs was significantly and clinically reduced by 45% with crizanlizumab (1.63 versus 2.98 with placebo; P=0.010). The median time to first VOC was also increased from 1.4 months with placebo to 4.1 months with crizanlizumab. The median annual rate of hospitalization days was reduced by 42% with crizanlizumab (4 versus 6.87 days with placebo).
As for the safety of crizanlizumab, the most common adverse reactions were arthralgia (18%), nausea (18%), back pain (15%), and pyrexia (11%).