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

Click here to­ read full press release/ article | Ref: Novartis | Image: City AM