Novartis’ Adakveo (crizanlizumab) Receives the US FDA’s Approval for Reducing the Frequency of VOCs in Sickle Cell Disease

Novartis’ Adakveo (crizanlizumab) Receives the US FDA’s Approval for Reducing the Frequency of VOCs in Sickle Cell Disease

Shots:

  • The US FDA’s approval is based on SUSTAIN study assessing Adakveo (5mg/kg, 2.5mg/kg) vs PBO in 198 patients in a ratio 1:1:1 aged ≥ 16yrs. with any genotype of sickle cell disease and a history of 2-10 VOCs/ pain crises in the previous 12 months
  • The SUSTAIN study results: 45% reduction in annual rate of VOCs (1.63 vs 2.98); 42% reduction in the annual rate of days hospitalized (4 vs 6.87days); patients not experiencing VOCs (36% vs 17%); median time to first VOC (4.1 vs 1.4 mos.)
  • Adakveo (SEG101, 5 mg/kg) is a first & only biologic targeting P-selectin, thus blocks the interaction b/w endothelial cells, platelets, red blood cells, and leukocytes and is expected to be available in the coming weeks

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