Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease
Crizanlizumab is a monthly infusion under development to prevent pain crises (also called vaso-occlusive crises, or VOCs) in patients with sickle cell disease. Sickle cell VOCs, which are triggered by multi-cell adhesion or clusters of cells that block or reduce blood flow, are associated with increased morbidity and mortality1 FDA filing of crizanlizumab anticipated in first half of 2019 Basel, January 8, 2019 - Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic complications2. VOCs happen when multiple blood cells stick to each other and to blood vessels, causing blockages1,3. Treatments that make blood cells and blood vessels less sticky may help reduce the number of days patients experience VOCs. "Painful sickle cell crises matter because they can disrupt patients' lives, and often require hospital visits and medical attention," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development.
