FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101) - Seite 3

About crizanlizumab (SEG101)
Crizanlizumab (SEG101) is an investigational humanized monoclonal antibody blocking P-selectin mediated multicellular adhesion that is in late-stage development for the prevention of vaso-occlusive crises (VOCs), also known as pain crises, in patients with sickle cell disease (SCD). Crizanlizumab binds to a molecule called P-selectin on the surface of platelets and endothelium in the blood vessels, and has been shown to inhibit interactions between endothelial cells, platelets, red blood cells, sickled red blood cells, and leukocytes. P-selectin is one of the major drivers of the vaso-occlusive process. Our goal is to deepen understanding of the true impact of VOCs on patients' bodies and lives and to explore how crizanlizumab can help to achieve more pain-crisis-free days for patients with SCD[4].

The SUSTAIN clinical study is one of the clinical studies in the SENTRY clinical trial program for crizanlizumab. Major active trials in the SENTRY program include:

• SOLACE-adults (A2202) Phase II study investigating the pharmacological properties and safety of crizanlizumab in patients with sickle cell disease aged 16 and above
• SOLACE-kids (B2201) Phase II study investigating the appropriate dosing, safety, and efficacy of crizanlizumab in pediatric patients with sickle cell disease
• STAND (A2301) Phase III study investigating the efficacy and safety of crizanlizumab in sickle cell disease patients aged 12 and above
• SUCCESSOR retrospective cohort study among adult sickle cell disease patients in the US

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