Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study

Novartis International AG / Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Data published in the American Journal of Hematology show more than twice as many patients taking crizanlizumab did not experience a disease-related pain crisis (also called vaso-occlusive crisis, or VOC) vs placebo
   

VOCs are the most common, painful complication of sickle cell disease and the main reason patients seek medical care in hospitals
 

Discussions with health authorities continue; FDA filing anticipated in 2019

Basel, October 9, 2018 - Results from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab, a humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been published in the American Journal of Hematology. The analysis showed that more patients treated with crizanlizumab did not experience a vaso-occlusive crisis (VOC) vs those treated with placebo (35.8% vs 16.9%), specifically patients with a history of 2-10 VOCs in the previous year.

VOCs are a painful complication of SCD and the main reason why patients seek medical care in hospitals[1],[2]. VOCs, which are triggered by multi-cell adhesion, are associated with increased morbidity and mortality, and can result in stroke, as well as organ damage or failure[3],[4]. Currently, treatment options for VOCs are limited[5].

"The unpredictable, intense painful crises that patients with sickle cell disease experience are the hallmark of the disease and the primary cause of hospitalizations in this patient population," said Abdullah Kutlar, MD, Director, Sickle Cell Center at the Medical College of Georgia, Augusta University, Augusta, Georgia, and primary author of the SUSTAIN analysis. "I am encouraged that results from this post hoc analysis of SUSTAIN study data found that crizanlizumab could substantially delay or prevent these crises, which also may mean less organ damage in the long run."