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Crizanlizumab (SEG101), Novartis‘ investigational compound for sickle cell disease (SCD), received breakthrough therapy designation from the U.S. Food and Drug Administration for its potential to prevent vaso-occlusive crises (VOCs).
The FDA designation was granted based on promising data from the company’s multicenter, randomized, double-blind, 52-week, Phase 2 SUSTAIN clinical trial (NCT01895361).
“Painful sickle cell crises matter because they can disrupt patients’ lives, and often require hospital visits and medical attention,” Samit Hirawat, MD, head of global drug development at Novartis Oncology, said in a press release. “We look forward to working closely with the FDA over the coming months toward making crizanlizumab, a therapy that has the potential to prevent sickle cell pain crises, available in the U.S. as soon as possible.”
education & researchA randomized controlled trial comparing two vaso-occlusive episode (VOE) protocols in sickle cell disease (SCD)Limited evidence guides opioid dosing st...
videos & visualsSickle Cell Patients are Innocent Victims of the Opioid Epidemic: Samir K. Ballas, MDhttps://www.youtube.com/watch?v=BOhY_gJo...
news & eventsSickle Cell Disease Research Shows Progress in Preventing Related Complications and DeathStudies aim to limit pain crises, preven...
news & eventsResearch Team Recognized for Organ-on-a-Chip DesignSCD is a group of genetic disorders that...
news & eventsAPS Scientific Meeting 2019The American Pain Society will hold its ...
education & researchRandomized phase 2 study of GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased ...Treatment of vaso-occlusive crises (VOC)...
news & eventsFDA Awards UNC Researcher $2M Grant to Study Kidney Disease in Sickle Cell AnemiaThe U.S. Food and Drug Administration (F...
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.