Novartis drug crizanlizumab shown to prolong time to patients’ first sickle cell pain crisis in subgroup analysis of SUSTAIN study
Investigational therapy crizanlizumab (SEG101, formerly SelG1) approximately doubled the time to first on-treatment sickle cell pain crisis, according to new subgroup analysis of Phase II SUSTAIN data. Results were consistent across patient subgroups despite differences in disease severity, genotype or background therapy New findings for crizanlizumab, a potential disease-modifying, preventive treatment option for patients with sickle cell disease, presented at ASH 2017 Discussions with health authorities continue; FDA filing anticipated by end of 2018 pending outcome of ongoing healthy volunteer bridging study Basel, December 11, 2017 - Results from a post hoc subgroup analysis of the Phase II SUSTAIN study show that crizanlizumab, an investigational humanized anti-P-selectin monoclonal antibody, delayed the time to first sickle cell pain crisis (SCPC) in patients vs. placebo in key subgroups of adult patients with sickle cell disease. Findings were featured during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract #613; Monday, December 11, 10:30 AM ET). Acute sickle cell pain crises, also referred to as vaso-occlusive crises, are a common painful complication of the disease and the main reason that patients seek medical care in hospitals. Currently, treatment options are limited. The data from a subgroup analysis of the Phase II SUSTAIN study showed that crizanlizumab, at 5.0 mg/kg per month increased the time to SCPC in patients on treatment, including those in high-risk subpopulations and with hydroxyurea use.
