Shots:

• The approval is based on the P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg- IV- q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks.
• The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%)- patients also experienced a reduction in the level of ApoB- non-HDL-C. Reductions in LDL-C were observed as early as weeks 2 and maintained throughout week 24 and the open-label trial period (through week 48).
• Evinacumab is a mAb targeting ANGPTL3 and is under FDA’s PR following the BTD granted in 2017

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