The US Food and Drug Administration (FDA) has given Novartis’ investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review. The governing body accepted the company’s Biologics License Application (BLA) which was submitted for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD) and was granted Breakthrough Therapy designation in December 2018. The submission is supported by Phase II results from the SUSTAIN study, which showed that crizanlizumab (5 mg/kg) reduced the median annual rate of VOCs leading to health care visits by 45.3% compared with placebo.

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