The FDA has approved use of the drug crizanlizumab based on the results of a clinical trial led by Kenneth Ataga, MD, Plough Foundation Endowed Chair in Sickle Cell Disease and director of the Center for Sickle Cell Disease at the University of Tennessee Health Science Center (UTHSC).
Dr. Ataga, who is also the director of the Memphis Consortium for Sickle Cell Disease and Non-Malignant Hematology Research, was the lead principal investigator of the multicenter, Phase II SUSTAIN trial. Part of a larger program of studies, the SUSTAIN trial was designed to test the safety and efficacy of crizanlizumab in reducing the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients ages 16 years and older with sickle cell disease.
The study participants were recruited from 60 sites in the United States, Brazil and Jamaica. Considered the clinical hallmark of the disease, sickle cell pain crises are unpredictable, severe events associated with life-threatening complications.