Novartis Reports FDA’s Acceptance of BLA for Crizanlizumab (SEG101) to Treat Sickle Cell Disease

Shots:

• The US FDA has accepted Novartis’ BLA and has granted Priority Review for crizanlizumab to prevent vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD)
• The FDA submission is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO further resulting in a reduction in VOCs (36% vs 17%), m-time to first VOC (4.07 vs 1.38 mos.), 42% reduction in annual rates of hospitalization days
• Crizanlizumab is a mAb targeting P-selectin mediated multicellular adhesion for the prevention of VOCs in patients with SCD, being evaluated in multiple studies for SCD in different age groups

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