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Crizanlizumab designated FDA breakthrough therapy for potential in vaso-occlusive crisis prevention
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.”
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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.